Billing Code 3410-DM-P DEPARTMENT OF AGRICULTURE ... · Under this final rule, establishments, except for very low- volume establishments, are required to collect carcass samples

Advance copy of document submitted to Office of the Federal Register. May be subject to minor changes.

1

Billing Code 3410-DM-P

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 301, 309, and 310

[Docket No. FSIS-2016-0017]

RIN 0583-AD62

Modernization of Swine Slaughter Inspection

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final Rule.

SUMMARY: The Food Safety and Inspection Service (FSIS) is

amending the Federal meat inspection regulations to establish an

optional new inspection system for market hog slaughter

establishments that has been demonstrated to provide public

health protection at least equivalent to the existing inspection

system. Market hog slaughter establishments that do not choose

to operate under the new swine inspection system may continue to

operate under their existing inspection system. The Agency is

also making several changes to the regulations that will affect

all establishments that slaughter swine, regardless of the

inspection system under which they operate or the age, size, or

class of swine. These changes will allow all swine slaughter

establishments to develop sampling plans that are more tailored

to their specific operations, and thus more effective in


2

monitoring their specific process control, unlike the current

requirements in the regulations.

DATES: Effective date: [INSERT DATE 60 DAYS FROM DATE OF

PUBLICATION IN THE FEDERAL REGISTER].

Notification Date: All market hog establishments will initially

have until [INSERT DATE 180 DAYS FROM DATE OF PUBLICATION IN THE

FEDERAL REGISTER] to notify their FSIS District Office (DO) of

their intent to operate under the New Swine Slaughter Inspection

System (NSIS). Establishments that do not notify their DO of

their intent by [INSERT DATE 180 DAYS FROM DATE OF PUBLICATION

IN THE FEDERAL REGISTER] will be deemed to have chosen to

continue operating under their existing inspection system.

Market hog establishments that decide that they would like to

convert to NSIS after the initial notification date may notify

their DO of their intent at any time after that date. The Agency

will implement NSIS in the additional establishments that intend

to convert on a schedule consistent with the availability of

Agency resources and establishment readiness. The Agency intends

to implement NSIS in all market hog establishments that choose

to operate under this new inspection system, regardless of when

the establishment notifies FSIS of its intent to transition to

NSIS. However, the initial implementation wave will only include

those establishments that submit their intent to convert to NSIS

within the initial notification period.


3

Applicability Dates: The regulations that prescribe procedures

for controlling contamination throughout the slaughter and

dressing process in 9 CFR 310.18(c), and the regulations that

prescribe recordkeeping requirements in 9 CFR 310.18(d), will be

applicable as follows:

In large establishments, defined as all establishments

with 500 or more employees, on [INSERT DATE 90 DAYS AFTER

PUBLICATION IN THE FEDERAL REGISTER];

In small establishments, defined as all establishments

with 10 or more employees but fewer than 500 employees, on

[INSERT DATE 120 DAYS AFTER PUBLICATION IN THE FEDERAL

REGISTER]; and

In very small establishments, defined as all

establishments with fewer than 10 employees or annual sales of

less than $2.5 million, on [INSERT DATE 180 DAYS AFTER

PUBLICATION IN THE FEDERAL REGISTER].

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant

Administrator, Office of Policy and Program Development;

Telephone: (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Executive Summary

On February 1, 2018, FSIS published a proposed rule to

modernize swine slaughter inspection (83 FR 4780). This final


4

rule adopts, with modifications, the provisions in the proposed

rule.

FSIS is establishing an optional new inspection system for

market hog slaughter establishments, NSIS, informed by the

Agency’s experiences under its Hazard Analysis and Critical

Control Point (HACCP)-Based Inspection Models Project (HIMP).

FSIS is establishing NSIS to improve the effectiveness of market

hog slaughter inspection; make better use of the Agency’s

resources; and remove unnecessary regulatory obstacles to

industry innovation by revoking maximum line speeds and allowing

establishments flexibility to reconfigure evisceration lines.

NSIS may also facilitate pathogen reduction in pork products and

improve compliance with the Humane Methods of Slaughter Act

(HMSA) (7 U.S.C. 1901 et seq.).

Because this final rule requires establishment personnel in

NSIS establishments to sort and remove unfit animals before

ante-mortem inspection by FSIS inspectors and trim and identify

defects on carcasses and parts before post-mortem inspection by

FSIS inspectors, the Agency’s inspectors will be presented with

healthier animals and carcasses that have fewer defects,

allowing them to conduct a more efficient inspection of each

animal and each carcass. As a result, under NSIS, FSIS can

assign fewer inspectors to online inspection, freeing up Agency

resources to conduct more offline inspection activities that are


5

more effective in ensuring food safety, such as verifying

compliance with sanitation and HACCP, as well as humane handling

requirements.

Key elements of the NSIS include: (1) requiring

establishment personnel to sort and remove unfit animals before

ante-mortem inspection by FSIS inspectors and to trim and

identify defects on carcasses and parts before post-mortem

inspection by FSIS inspectors; (2) requiring establishment

personnel to identify animals or carcasses, that they have

sorted and removed for disposal before FSIS inspection, with a

unique tag, tattoo, or similar device, and to develop,

implement, and maintain written procedures in their HACCP system

to ensure that animals and carcasses sorted and removed for

disposal do not enter the human food supply and are properly

disposed of according to 9 CFR part 314; (3) requiring

establishments to maintain records to document the total number

of animals and carcasses sorted and removed per day and the

reasons for their removal; (4) requiring establishment personnel

to immediately notify FSIS inspectors if they identify, while

conducting sorting activities, an animal or carcass that they

suspect has a reportable or foreign animal disease (e.g.,

African swine fever, classical swine fever, or Nipah virus

encephalitis); (5) shifting Agency resources to conduct more

offline inspection activities that are more effective in


6

ensuring food safety, which allows for up to two offline

verification inspectors per line per shift and reduces the

number of online inspectors to a maximum of three per line per

shift; (6) requiring establishments to maintain records

documenting that products resulting from their slaughter

operations meet the new definition of ready-to-cook (RTC) pork

product, which is any slaughtered pork product sufficiently free

from bile, hair, scurf, dirt, hooves, toe nails, claws, bruises,

edema, scabs, skin lesions, icterus, foreign material, and odor

which is suitable for cooking without need of further

processing; and (7) revoking maximum line speeds and authorizing

establishments to determine their own line speeds based on their

ability to maintain process control for preventing fecal

contamination and meeting microbial performance measures for

carcasses during the slaughter operation. FSIS retains the

ability to slow or stop the line, as needed (9 CFR 310.26(c)).

Based on its experience under HIMP, the NSIS is unlikely to

result in a higher prevalence of Salmonella on market hog

carcasses and may result in a lower prevalence of Salmonella on

market hog carcasses, which in turn may lead to fewer human

illnesses. In addition, FSIS expects that the new inspection

system will improve animal welfare and compliance with the HMSA

because more FSIS resources will be available to verify the

humane handling of animals.


7

Under the NSIS, establishment sorters will be required to

incise mandibular lymph nodes and palpate the viscera to detect

the presence of animal diseases (e.g., Mycobacterium (M.) Avium)

as part of their sorting activities before FSIS post-mortem

inspection (9 CFR 310.26(b)). The Agency determined that it

needs more information on the public health impact of these

sorting activities before it can allow establishments to decide,

on a lot-by-lot basis, whether establishment sorters need to

incise lymph nodes and palpate the viscera to detect the

presence of animal diseases. To gather this information, FSIS

has decided to allow establishments that operate under the NSIS

to apply for waivers to 9 CFR 310.26(b) under 9 CFR 303.1(h). As

a condition of the waiver, establishments operating under

waivers are required to submit data to FSIS. FSIS then assesses

that data to determine whether changes to the regulations are

appropriate and necessary. The Agency will announce the criteria

for these waivers in a future Federal Register document.

Under this final rule, market hog slaughter establishments

that do not choose to operate under the NSIS may continue to

operate under traditional inspection (i.e., inspection described

in current regulations). Establishments that slaughter swine

other than market hogs are not eligible to operate under the

NSIS unless they obtain a waiver under the Salmonella Initiative

Program (SIP) (79 FR 633, January 6, 2014).


8

Under this final rule, FSIS is also making several changes

that will affect all establishments that slaughter swine,

regardless of the inspection system under which they operate.

Specifically, all official swine slaughter establishments must

develop, implement, and maintain in their HACCP plans,

sanitation standard operating procedures (sanitation SOPs), or

other prerequisite programs (hereafter collectively referred to

as their “HACCP systems”), written procedures to prevent the

contamination of carcasses and parts by enteric pathogens, and

visible fecal material, ingesta, and milk throughout the entire

slaughter and dressing operation. These procedures must include

sampling and analysis for microbial organisms to monitor process

control for enteric pathogens, as well as written procedures to

prevent visible fecal material, ingesta, and milk contamination.

As part of their written procedures, establishments will be

required to collect and test two carcass samples for microbial

organisms, one at pre-evisceration and one at post-chill (i.e.,

the point in the slaughter process after the carcass has chilled

in the cooler and after all slaughter interventions are

completed), or, for very low-volume establishments, a single

post-chill carcass sample. Establishments that bone their

products before chilling (i.e., hot-boned products) will be

required to collect the pre-evisceration sample and a sample


9

after the final wash instead of at post-chill, because these

products are not chilled before further processing.

Under this final rule, establishments, except for very low-

volume establishments, are required to collect carcass samples

and test for microbial organisms pre-evisceration and post-

chill, or, for hot-boned products, pre-evisceration and after

the final wash, at a frequency of once per 1,000 carcasses. Very

low-volume establishments are required to collect at least one

carcass sample during each week of operation starting June 1 of

each year. If, after consecutively collecting and testing 13

weekly carcass samples, very low-volume establishments can

demonstrate that they are not exceeding their upper control

limit for microbial organisms and that they are effectively

maintaining process control, they can modify their sampling

plans to collect samples less frequently. FSIS provides more

information on upper control limits in its guideline titled

Developing Effective Microbiological Sampling Programs in Swine

Slaughter Establishments to Assess Process Control and Sanitary

Conditions (hereafter referred to as the sampling guideline).

The sampling guideline is available on FSIS’s Web site at

https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-

compliance/compliance-guides-index.

This final rule rescinds the current requirement that swine

establishments test carcasses for generic E. coli post chill to


10

monitor process control and replaces this requirement with the

new testing requirements described above. The new testing

requirements will allow establishments to develop sampling plans

that are more tailored to their specific operation, and thus

more effective in monitoring their specific process control than

the current generic E. coli criteria. This final rule also

removes the codified Salmonella pathogen reduction performance

standard for hogs (carcasses) because verifying the codified

standard was not a good use of Agency resources. As FSIS

explained in the proposed rule (83 FR 4780, 4786), the Agency

discontinued its Salmonella verification sampling program for

market hogs in 2011 because the estimated prevalence of

Salmonella on hog carcasses was low, and FSIS did not find

enough pathogen positives to justify the resources needed (e.g.,

time and supplies) to conduct carcass swabbing.

This final rule does not allow establishments to collect

samples for microbial organisms at alternative sampling

locations or frequencies, as was proposed. FSIS made this change

from the proposed rule in response to comments that it may be

too difficult for inspection personnel to review and verify

sampling plans with alternative sampling locations or

frequencies. Establishments that currently operate under SIP

waivers from the former generic E. coli regulations may continue

to conduct process control sampling at the alternative


11

frequencies provided for in their waivers. All other SIP waivers

(e.g., waivers for 9 CFR 310.1(b)(3)— line speed; 9 CFR

310.25(b)—Salmonella performance standards; 9 CFR 310.18(a)—

contamination of organs; and 9 CFR 310.14— handling of bruised

parts) will end. FSIS will allow other establishments that would

like to experiment with alternative sampling locations and

frequencies to submit waiver requests under the SIP to FSIS.

FSIS will announce new waiver criteria in a future Federal

Register document. This final rule also does not require swine

slaughter establishments to develop, implement, and maintain in

their HACCP systems written procedures to prevent contamination

of the pre-operational environment by enteric pathogens, as was

proposed. FSIS has decided to withdraw this part of the proposal

until the Agency considers its options and timing for gathering

more data on contamination in the pre-operational environment. A

summary of changes to the proposed rule is included below under

section I. Background.

In Table 1 below, FSIS presents the estimated costs and

benefits of the final rule. The regulatory impact analysis

section below contains an explanation of the assumptions,

provides alternative adoption scenarios, and includes a

discussion of the uncertainty surrounding the net benefits

associated with how much of the industry will choose to adopt

NSIS.


12

Table 1: Net Costs and (Benefits)(M$)

Number of Establishments

One-Time Recurring

Costs to Industry $3.14 $22.72 Voluntary* 40** $0.84 $22.15 Mandatory 612 $2.30 $0.58

Health Benefits*** ($9.33) Industrial Efficiency ($87.64) Impacts to Agency's Budget $2.80 ($8.73)

Totals

One-Time Cost $5.94

Recurring Cost ($82.98) Annualized Costs, Assuming a 3% Discount Rate

Over 10 Years ($62.56)

Annualized Costs, Assuming a 7% Discount Rate Over 10 Years

($60.00)

* Further explanation and details on the NSIS adoption rate are provided in section G. Potential Cost of the Final Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 26: Quantified Cost and (Benefits) of Various Adoption Rates ** Note, this includes 5 HIMP establishments, which are not expected to incur any costs or benefits associated with the NSIS. *** Further explanation and details on the range of health benefits have been provided in section H. Potential Benefits of the Final Rule, Table 18: Health Benefits from Averted Cases of Salmonella. The value of health benefits ranges from a $6.33 million decrease to a $24.62 million increase in health benefits, with a mean increase in benefits of $9.33 million, assuming a cost per illness of $3,682. **** Note, some of the totals may not equal the sum due to rounding.

Table of Contents

I. Background

II. Comments and Responses

III. Executive Orders 12866 and 13563

IV. Regulatory Flexibility Act Assessment

V. Executive Order 13771

VI. Congressional Review Act


13

VII. E-Government Act

VIII. Executive Order 12988, Civil Justice Reform

IX.. Executive Order 13175

X. USDA Nondiscrimination Statement

XI. Environmental Impact

XII. Paperwork Reduction Act

XIII. Additional Public Notification

XIV. Final Regulatory Amendments

I. Background

FSIS began experimenting with new approaches to slaughter

inspection based on HACCP principles shortly after publishing

the Pathogen Reduction/HACCP rule in 1996. In 1997, the Agency

developed the HIMP pilot study to determine whether applying new

government slaughter inspection procedures, with new

establishment responsibilities, could promote industry

innovation and provide at least the same food safety and

consumer protection as the other available slaughter inspection

systems. FSIS initiated the HIMP pilot study in 20 young

chicken, five young turkey, and five market hog establishments

on a waiver basis.

In 2014, the Agency amended the poultry products inspection

regulations to establish an optional new inspection system for

young chicken and all turkey slaughter establishments informed

by the Agency’s experiences under HIMP (79 FR 49566, August 21,


14

2014). The New Poultry Inspection System (NPIS) was designed to

facilitate pathogen reduction in poultry products, improve the

effectiveness of poultry slaughter inspection, make better use

of the Agency's resources, and remove unnecessary regulatory

obstacles to innovation.

In addition to establishing the NPIS for young chickens and

turkeys, FSIS also amended the poultry products inspection

regulations that apply to all establishments that slaughter

poultry other than ratites. The new requirements ensure that all

poultry slaughter establishments implement appropriate measures

in their HACCP systems to prevent contamination of carcasses and

parts by enteric pathogens and visible fecal material throughout

the entire slaughter operation and ensure that both FSIS and

establishments have the documentation they need to verify the

effectiveness of these measures on an ongoing basis.

Proposed Rule

On February 1, 2018, FSIS proposed to amend the meat

inspection regulations to establish an optional new slaughter

inspection system for market hog establishments (83 FR 4780).

FSIS also proposed several changes to the regulations that would

affect all establishments that slaughter swine, regardless of

the inspection system under which they operate or the age, size,

or class of swine.


15

The proposed rule’s comment period closed on May 2, 2018,

90 days after its publication. After reviewing comments on the

proposed rule, FSIS is finalizing, with some changes, the

provisions in the February 2018 proposed rule. In this final

rule, the Agency is modifying its proposal to:

• Establish a phased approach to implement the NSIS;

• Establish separate applicability dates for large, small,

and very small establishments to comply with the provisions

in the rule that prescribe the new recordkeeping and

microbiological sampling requirements that will apply to

all establishments that slaughter swine. The applicability

dates will provide additional time for small and very small

establishments to comply with these provisions;

• Revise the disposal requirements to require establishments

operating under the NSIS to develop, implement, and

maintain written procedures in their HACCP systems to

ensure that animals and carcasses that have been sorted and

removed for disposal do not enter the human food supply and

are properly disposed of according to 9 CFR part 314;

• Require establishments operating under the NSIS to maintain

records to document the total number of animals and

carcasses sorted and removed per day and the reasons for


16

their removal and make these records available for review

and evaluation by FSIS;

• Clarify that all establishments operating under the NSIS

must provide a mirror at the carcass inspection station;

• Clarify that establishments that bone their products before

chilling (i.e., hot-boned products) must collect a carcass

sample pre-evisceration and after the final wash instead of

at post-chill. These establishments must also collect a

sample at the pre-evisceration point in the process;

• Withdraw the proposal to allow establishments to use

alternative sampling locations and sampling frequencies;

• Revise the sampling regulations to require very small

establishments that slaughter more than 20,000 swine, or a

combination of swine and other livestock exceeding 6,000

cattle and 20,000 total of all livestock to collect two

carcass samples, one at pre-evisceration and one at post-

chill, at a frequency of 1 per 1,000 carcasses, instead of

a single post-chill sample;

• Require establishment sorters to incise mandibular lymph

nodes and palpate the viscera to detect the presence of

animal diseases (e.g., M. Avium) as part of their sorting

activities before FSIS post-mortem inspection;


17

• Revise the definition of “RTC pork product” to clarify that

the standard is a performance standard for non-food safety

defects and not a zero-tolerance standard; and

• Withdraw the proposed requirement for swine slaughter

establishments to develop, implement, and maintain in their

HACCP systems written procedures to prevent contamination

of the pre-operational environment by enteric pathogens.

Hog HIMP Report

The proposed rule was informed by the Agency’s

comprehensive analysis of data collected from HIMP market hog

establishments. In 2014, the Agency evaluated inspection

findings in market hog slaughter establishments participating in

HIMP to determine whether the HIMP inspection system performs as

well as the existing inspection system in terms of safety and

wholesomeness of the products produced and of overall consumer

protection. FSIS summarized its findings in its report titled

“Evaluation of HACCP Inspection Models Project (HIMP) for Market

Hogs” (hereafter the “Hog HIMP Report”)1 and in the proposed rule

(83 FR 4780, 4789). The Hog HIMP Report concluded that market hog

slaughter establishments participating in HIMP are performing as

well as comparable large non-HIMP market hog establishments.

1 The Hog HIMP Report is available on the FSIS website at: http://www.fsis.usda.gov/wps/wcm/connect/f7be3e74-552f-4239-ac4c-59a024fd0ec2/Evaluation-HIMP-Market-Hogs.pdf?MOD=AJPERES.


18

The Hog HIMP Report is based on two time periods: the years

CY2006 - CY2010 and the years CY2012 - CY2013. The evaluation

compared 5 HIMP market hog establishments with a comparison set

of 21 non-HIMP market hog slaughter establishments selected to

be comparable with HIMP market hog establishments with respect

to production volume, line speed, and days of slaughter

operation.

The Hog HIMP Report found that HIMP market hog

establishments received more off-line food safety related

inspection verification checks than the traditional non-HIMP

market hog establishments. HIMP market hog establishments had

higher compliance with Sanitation SOP and HACCP regulations,

lower levels of non-food safety defects, equivalent or better

Salmonella verification testing positive rates than traditional

non-HIMP market hog establishments, and lower levels of

violative chemical residues. The Hog HIMP Report also found that

under HIMP, market hog establishments received an increased

level of Sanitation SOP and HACCP inspection. Based on these

findings, HIMP has been demonstrated to provide public health

protection at least equivalent to the traditional inspection

system.

Risk Assessment

The proposed rule was also informed by FSIS’s Assessment of

the Potential Change in Human Risk of Salmonella Illnesses


19

Associated with Modernizing Inspection of Market Hog Slaughter

Establishments. The risk assessment2 used available data from

FSIS's microbiological baseline studies3 and the Agency's

Salmonella verification results from swine slaughter

establishments. FSIS employed a stochastic simulation model

using multi-variable logistic regressions to identify

correlations between (1) the numbers of offline food-safety

inspection procedures, both scheduled and unscheduled, along

with the numbers of non-compliances and scheduled-but-not-

completed procedures,4 and (2) contamination of hog carcasses

with Salmonella. The correlations were used to predict the

potential effect that devoting more resources to those offline

procedures might have on human illness attributable to the

consumption of pork products. Stochastic simulations were used

to account for statistical uncertainty in the estimates relating

inspection procedures in an establishment to detection of

2 As FSIS explained in the proposed rule, the Agency used a similar approach to estimate the public health benefits associated with the final rule titled Modernization of Poultry Slaughter Inspection (79 FR 49565). 3 FSIS baseline data is available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/baseline/baseline. 4 Scheduled procedures are assigned to inspectors at an establishment by the Public Health Information System (PHIS). Before FSIS implemented the PHIS, scheduled procedures were assigned by the Performance-Based Inspection System (PBIS). Unscheduled procedures are performed according to inspector needs at an establishment and may include verification checks for fecal material, ingesta, and milk, or they may be a response to unforeseen hazards or unsanitary conditions arising from sanitation SOP failures, or the need to verify corrective actions taken under the establishment's HACCP plan.


20

Salmonella in samples from hog carcasses.5 Illness estimates were

based on data from the Centers for Disease Control and

Prevention (CDC), and uncertainty distributions were used to

account for the variability in annual Salmonella illnesses and

statistical uncertainty about the relationship between the

pathogen prevalence levels at the establishments and the

corresponding annual number of illnesses that could be

attributed to the pathogens.

As with any risk assessment, FSIS’s risk assessment relies

on a number of assumptions. FSIS assumed that the differences

between the approach to slaughtering hogs and slaughtering

poultry would not alter the relationship between the presence of

Salmonella contamination on carcasses and the likelihood of

contamination of meat and human illness. Furthermore, hog

slaughter establishment specialization has been facilitated by

vertical integration within the industry, much like the poultry

industry.6 FSIS also assumed, for the purpose of this risk

assessment, that the relationship between Salmonella

contamination of hog carcasses and downstream products such as

pork parts (e.g., pork chops) and ground pork closely mirrors

5 For the risk assessment, FSIS used data from The Nationwide Microbiological Baseline Data Collection Program: Market Hogs Survey August 2010-2011 available at http://www.fsis.usda.gov/wps/wcm/connect/d5c7c1d6-09b5-4dcc-93ae-f3e67ff045bb/Baseline_Data_Market_Hogs_2010-2011.pdf?MOD=AJPERES). 6 Muth, M. (2007). Pork Slaughter and Processing Sector Facility-Level Model. https://www.rti.org/sites/default/files/resources/muth_pork-slaughter_final.pdf.


21

that of the established relationship between Salmonella

contamination of poultry (e.g., chicken) carcasses and

downstream products such as chicken parts and ground chicken. On

the other hand, the likelihood of positive Salmonella findings

on hog carcasses is significantly lower than on chickens. While

FSIS did not conduct any specific analyses to examine this

assumption, the Agency has conducted numerous peer-reviewed

analyses of the relationship between Salmonella contamination

frequency on chicken carcasses and chicken parts.7 These analyses

indicate that the prevalence of Salmonella contamination on

downstream products (e.g., parts) often exceeds the frequency of

measurement of Salmonella contamination in upstream products

(e.g., carcasses), and the Agency expects this relationship

would apply to other amenable species slaughtered in FSIS

establishments. The assumption of higher prevalence is logical

given that samples of downstream products contain primals from

multiple carcasses, increasing the likelihood of a single sample

being contaminated.

The regression analysis of the historical data included in

the market hog risk assessment showed a statistically

significant correlation between (1) increased scheduled and

7 Ebel, E.D., Williams, M.S., Tameru, B. (2019) Relatedness of Salmonella contamination frequency on chicken carcasses and parts when processed in the same establishment. Food Control 100: 198-203.


22

unscheduled offline procedures and decreased scheduled but not

performed procedures and (2) reduction in the prevalence of

Salmonella positive samples from carcasses. Based on these

results, the redeployment of Agency resources to scheduled and

unscheduled offline activities, along with a reduction in

scheduled but not performed procedures, is likely to contribute

to food safety resulting from a lower prevalence of carcasses

contaminated with Salmonella, which in turn the Agency expects

to lead to fewer human illnesses. FSIS will evaluate policy

effectiveness by routinely analyzing inspection task data in

PHIS (e.g., NRs for regulations on the PHR list, including NRs

for HACCP, sanitation SOP, and Livestock Zero Tolerance tasks).

In April 2018, the Agency conducted an external peer review

of the risk assessment. On August 6, 2018, FSIS posted a revised

version of the risk assessment on its Web site at

https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/fed

eral-register/proposed-rules. The revised risk assessment

addressed reviewers’ comments that FSIS should have used

different modeling approaches. The revised risk assessment also

included an in-depth power analysis, multicollinearity

diagnostics, model parameters and estimates when more complex

crossover and mixed-effects modeling approaches were applied,

and a summary of all alternative models (Appendix H). The

revisions made in response to the reviewers’ comments did not


23

produce changes to the risk assessment’s conclusions that would

require modifications of the proposed rule. However, the Agency

gave interested persons 30 days (until September 5, 2018) to

comment on the changes made to the risk assessment. To be

transparent, FSIS has decided to add text to the risk assessment

to better characterize the two different models that were

conducted (see Tables 13 and 14 in the risk assessment and

accompanying text). Specifically, FSIS has added additional

language to the risk assessment—both in the summary and in the

discussion—to highlight the results of the modeling without

simulated data. To that end, the results of the modeling with

simulated data—which, as would be expected, had less uncertainty

around the estimated change in illnesses-are not used in support

of this rule. The modeling without simulated data is now carried

through in the Regulatory Impact Analysis. The result of those

additions is that the uncertainty around estimated illnesses

avoided is greater; however, the most likely estimated illnesses

avoided are not affected. Notably, FSIS received a comment

questioning FSIS’s use of simulated data. FSIS believes that

this change addresses the commenter’s questions.

Additionally, minor edits and corrections for clarity and

consistency were made in the main body of the risk assessment

report. The most likely estimates of illnesses avoided from

converting from traditional inspection to the NSIS did not


24

change with incorporation of these additional analyses and other

minor changes to the risk assessment.

The final risk assessment is available on FSIS’s Web site at

https://www.fsis.usda.gov/wps/portal/fsis/topics/science/risk-

assessments. FSIS is responding to comments received regarding

the risk assessment in Part C of section II. “Comments and

Responses” below.

II. Comments and Responses

FSIS received over 83,000 comments in response to the

February 2018 proposed rule and five comments on the revised

risk assessment. Most of these comments were form letters

submitted as part of various write-in campaigns initiated by

consumer advocacy organizations, animal welfare organizations,

labor unions, and worker advocacy organizations. FSIS also

received individual comments from private citizens.

In addition to the form letters and individual comments,

the Agency also received comments from trade associations

representing the meat industry, companies that conduct swine

slaughter operations, consumer advocacy organizations, public

health organizations, animal welfare organizations, labor

unions, worker advocacy organizations, foreign countries, FSIS

inspectors, an environmental organization, and a State

Department of Agriculture. Below is a summary of the comments

and FSIS’s responses.


25

A. Requests for Public Meetings, Comment Extensions, and

Documents

Comments: Several consumer advocacy organizations, labor

unions, and worker advocacy organizations stated that FSIS

should have held public meetings to discuss the proposed rule.

According to the comments, public meetings focused on the

proposed rule may have helped to clarify the pros and cons of

important proposed changes. A few consumer advocacy

organizations argued that FSIS should have submitted the risk

assessment for peer review before publishing the proposed rule,

or, at least, extended the comment period for the proposed rule

until all stakeholders had the opportunity to read and respond

to the peer reviewed version of the risk assessment.

Response: Rather than hold a public meeting on the proposed

rule, the Agency held two webinars in March and April 2018, to

provide an overview of the proposed rule and provide the public

with an opportunity to ask questions about the proposed rule.

(Transcripts of the webinars are available on the FSIS Web site

at

https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/past

-meetings.) During the webinars, FSIS provided the public with

all the information that it would have provided during a public

meeting.


26

The Agency explained during the webinars and monthly

consumer and industry stakeholder meetings that it would reopen

the comment period for the proposed rule if the Agency had to

make significant changes to the risk assessment based on peer

review comments. And, even though FSIS did not have to make

significant changes to the risk assessment, the Agency reopened

the comment period on the risk assessment for an additional 30

days to give stakeholders an opportunity to comment on the

revised document.

In total, stakeholders had 90 days to review and comment on

the proposed rule and 120 days to review and comment on the risk

assessment. Executive Order (E.O.) 12866, as supplemented by

E.O. 13563, states that agencies are to “afford the public …

with a comment period that should generally consist of not less

than 60 days.” The Agency believes that the public had ample

time to consider the issues raised in the proposed rule and risk

assessment to develop their comments.

Comment: A few worker advocacy groups argued that FSIS

should have reopened the comment period on the proposed rule

because, according to the commenters, the Agency relied on an

unpublished data set of Occupational Safety and Health

Administration (OSHA) logs to compare worker injury rates

between HIMP and non-HIMP establishments.


27

Response: In the proposed rule, FSIS explained that the

Agency compared injury rates between establishments operating

under traditional inspection and HIMP (83 FR 4796). FSIS’s

analysis showed that HIMP establishments had lower mean injury

rates than non-HIMP establishments. The analysis used injury

rate data available on OSHA’s website.

FSIS further explained that the survey captured data from

OSHA logs of workplace injuries and illnesses, maintained by

employers as mandated by regulations (see 29 CFR part 1904), and

that 56 FSIS inspected market hog slaughter establishments

submitted their injury rate data to OSHA (83 FR 4796). From

these 56 establishments, FSIS explained that it excluded 27 low-

volume establishments, leaving 29 establishments (5 HIMP and 24

Traditional). The low-volume establishments were excluded to

provide a better comparison group of traditional establishments

because all HIMP establishments are high-volume establishments.

The results showed HIMP establishments had a lower mean number

of injuries using three OSHA injury rate measures: Total Case

Rate (TCR); Days Away, Restricted or Transferred (DART); and

Days Away from Work (DAFW). However, FSIS noted that factors

other than line speed may affect injury rates (e.g., automation

and number of sorters per line) and requested comments on worker

safety issues in the proposed rule as a result.


28

All the information that FSIS used in its analysis is

publicly available. FSIS does acknowledge that it did not

provided the web address for OSHA’s Establishment Specific

Injury and Illness Data, which is available at

https://www.osha.gov/pls/odi/establishment_search.html. However,

it is easy to find on OSHA’s Web site under the “Data” tab.

And, while FSIS did not post the exact data that the Agency

pulled from its Public Health Information System (PHIS) to

select swine slaughter establishments present in the OSHA data

set, the same information can be found in other formats on

FSIS’s Web site. Establishment level production volume

information is available at

https://www.fsis.usda.gov/wps/portal/fsis/topics/data-

collection-and-reports/data. This data would allow interested

parties to identify the high-volume establishments.

Additionally, the list of establishments participating in HIMP

is available at


compliance/haccp/haccp-based-inspection-models-project/HIMP-

list-of-participating-plants.

Although FSIS conducted an analysis of injury rates during

the development of the proposed rule, FSIS did not use the

analysis to draw conclusions on worker safety in HIMP or non-

HIMP establishments or whether there is an associated impact on


29

food safety. As discussed in more detail below, while FSIS

recognizes that working conditions in swine slaughter

establishments is an important issue, the Agency does not have

the authority to regulate issues related to establishment worker

safety. OSHA is the Federal agency with statutory and regulatory

authority to promote workplace safety and health.

Comment: A few commenters argued that FSIS violated the

Administrative Procedure Act (APA, 5 U.S.C. 551 et seq.) because

the Agency did not identify the 21 non-HIMP establishments that

it used to conduct its comparisons for the Hog HIMP Report or

post all the raw data that it used to develop the Hog HIMP

Report. According to the commenters, the APA requires reasoned

decision-making based on an examination of relevant data

articulated in a satisfactory explanation. The commenters argued

that because FSIS did not provide all its raw data, the Agency

failed to provide the public a meaningful opportunity to

participate in the rulemaking process.

Response: The APA does not require Federal agencies to post

all their raw data. That said, FSIS is committed to being

transparent and responsive to stakeholders. FSIS clearly

explained in the Hog HIMP Report that FSIS selected the 21 non-

HIMP establishments because they were large, high-volume market

hog slaughter establishments that had similar production volume,

line speed, and days of slaughter operation to the five market


30

hog slaughter HIMP establishments. FSIS also clearly explained

in the Hog HIMP Report and the proposed rule (83 FR 4780, 4789)

the Agency’s analysis of its inspection data and its conclusions

based on the data. Moreover, FSIS made every effort to respond

to FOIA requests related to the proposed rule before the close

of the comment period. The Agency has added all the information

that it has recently released to its FOIA Electronic Reading

Room.8

B. HIMP

Comment: Several consumer advocacy organizations, public

health organizations, animal welfare organizations, worker

advocacy organizations, and private citizens questioned whether

data collected under the HIMP pilot study should be used to

inform the NSIS. The commenters argued that the USDA’s Office of

the Inspector General (OIG) was critical of HIMP in its 2013

report.9 The commenters stated that OIG found that FSIS: did not

adequately oversee the HIMP program because it did not evaluate

whether the program resulted in a measurable improvement of the

inspection process; allowed one HIMP establishment to forgo the

standard FSIS policy to manually inspect viscera; and did not

have formal agreements with the HIMP establishments.

8 FSIS’s FOIA Electronic Reading Room is available at http://www.fsis.usda.gov/readingroom. 9 OIG, 2013. Food Safety and Inspection Service, Inspection and Enforcement Activities at Swine Slaughter Plants, https://www.usda.gov/oig/webdocs/24601-0001-41.pdf.


31

According to the commenters, OIG’s audit report also raised

issues with the Agency’s enforcement policies at all hog

slaughter operations, finding that FSIS’s policies did not deter

establishments from becoming repeat violators of food safety

regulations and that FSIS could not always ensure the humane

handling of animals.

In September 2013, the U.S. Government Accountability

Office (GAO) followed the OIG with a report entitled, More

Disclosure and Data Needed to Clarify Impact of Changes to

Poultry and Hog Inspections.10 According to the commenters, GAO

found that FSIS did not collect comparable data from

establishments participating and not participating in the HIMP

pilot study. The commenters also stated that GAO found that the

use of volunteer facilities raised questions about self-

selection bias and that information collected from the five

market hog slaughter HIMP establishments would not provide

reasonable assurance that any conclusions could apply more

broadly to all swine slaughter establishments because of the

small sample size.

Response: FSIS addressed OIG’s concerns in the Agency’s

responses to the audit. In response to the OIG audit, FSIS

updated its SIP letters (i.e., formal agreements), requiring all

10 GAO, 2013. More Disclosure and Data Needed to Clarify Impact of Changes to Poultry and Hog Inspections, http://www.gao.gov/assets/660/657144.pdf.


32

HIMP establishments to conduct the same viscera inspection

procedures, and implemented PHIS, enhancing the Agency’s ability

to better track trends in NRs.

In addition, the Agency implemented required supplemental

training after the release of the updated Directive 6900.2,

Humane Handling and Slaughter of Livestock, to improve

inspectors’ objective observation and assessment skills. The

Situation Based Humane Handling training modules (Module I and

Module II) effectively teach inspectors how to interpret an

egregious or non-egregious inhumane handling event objectively,

and to take appropriate enforcement actions. The training

modules contain fictional scenarios of inhumane and egregious

events and describe in detail how an inspector is to proceed

with regulatory enforcement.

Furthermore, in October 2013, FSIS announced that it hired

a Humane Handling Enforcement Coordinator, who conducts ongoing

reviews of relevant NRs, suspensions and Notices of Intended

Enforcement (NOIEs).11 To accomplish this, the Humane Handling

Enforcement Coordinator maintains a database to track the review

of NRs and the review and tracking of suspensions and NOIEs

pertaining to violations of the HMSA. The Humane Handling

11 https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-and-transcripts/news-release-archives-by-year/archive/2013/nr-102313-01.


33

Enforcement Coordinator also conducts correlations with

inspectors to help them improve their objective analysis when

enforcing the HMSA and related regulations, which serves to

reduce subjective interpretation of inhumane events and their

regulatory outcome.

To deter repeat violators, the Agency changed the way that

it schedules its in-depth reviews of establishments’ food safety

systems, known as food safety assessments (FSAs).12,13 In 2015,

FSIS implemented its Public Health Risk Evaluation (PHRE)

methodology, which consists of a decision-making evaluation that

helps Enforcement, Investigations and Analysis Officers (EIAOs)

and DOs determine if an FSA needs to be scheduled and conducted

or if enforcement action is warranted for a particular

establishment. The decision criteria used in the PHRE include

factors such as pathogen testing results, recalls, outbreaks,

regulatory findings, and inspection results at an establishment.

The PHRE methodology and the decision criteria are described in

detail in FSIS Directive 5100.4.14

12 See FSIS Directive 5100.1, Enforcement, Investigations and Analysis Officer (EIAO) Food Safety Assessment (FS) Methodology available at https://www.fsis.usda.gov/wps/wcm/connect/31bb8000-fb33-4b51-964b-1db9dfb488dd/5100.1.pdf?MOD=AJPERES. 13 See FSIS Directive 5100.4, Enforcement, Investigations and Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE) Methodology available at https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES. 14 FSIS Directive 5100.4, Enforcement, Investigations and Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE) Methodology available at https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES.


34

Rather than schedule routine FSAs every four years, FSIS’s

Office of Planning, Analysis and Risk Management (OPARM)

provides DOs with a prioritized list of establishments for PHREs

once per month based on public health risk triggers (e.g., if an

establishment has produced adulterated product). EIAOs review

historical data on the listed establishments and coordinate with

inspection program personnel assigned to the listed

establishments to determine if an FSA or other enforcement

action is needed. DOs can still schedule for cause PHREs at

establishments not on the prioritized list (i.e., if there is an

illness or outbreak, significant or repetitive contamination or

adulteration incidents, or repetitive microbiological sampling

failures). The use of the PHRE methodology allows FSIS to better

target establishments for FSAs based on risk and to more

effectively deploy its investigational resources (EIAOs).

In addition, FSIS developed PHIS alerts for inspection

personnel that are triggered when an establishment receives a

certain percentage of NRs for regulations on the Public Health

Regulation (PHR) list.15 The PHR list, which is updated annually

and posted on the Agency’s Web site, consists of regulations and

15 See FSIS Notice 15-18, Public Health Regulations and Alerts for use in Determining Inspection Program Personnel Actions and Public Health Risk Evaluation Scheduling in Meat and Poultry Establishments available at https://www.fsis.usda.gov/wps/wcm/connect/8f218f5b-197e-4813-bf92-be29be36ec08/15-18.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=8f218f5b-197e-4813-bf92-be29be36ec08.


35

specific provisions of regulations that historically have higher

rates of noncompliance three months before a pathogen positive

or enforcement action. Each month OPARM calculates a PHR NR rate

for each meat and poultry establishment and determines if an

establishment will be issued a PHR alert or if they should be

considered by the DO for a PHRE, which may lead to an FSA. PHIS

alerts have helped FSIS better identify trends that may warrant

an FSIS enforcement action.

The GAO report identified what it believed to be data gaps

in the HIMP pilot study and recommended that FSIS collect and

analyze information to determine if the HIMP pilot study was

meeting its purpose. FSIS agreed with the recommendation and

began working on the Hog HIMP Report. GAO also identified

strengths in the HIMP pilot study, including that of giving

establishments responsibility and flexibility for ensuring food

safety and quality and allowing FSIS inspectors to focus more on

food safety related activities.

While it is true that the five market hog slaughter HIMP

establishments represent a small sample size of establishments,

they collectively represent diversity in geography, corporate

structure, management styles, product distribution patterns, and

other variables. FSIS believes that the volunteer market hog

slaughter establishments participating in the HIMP pilot study,

viewed collectively, are typical of the broader industry.


36

Comment: Some consumer advocacy groups questioned why the

Agency did not use a third-party contractor to conduct its

evaluation of the hog HIMP pilot study.

Response: FSIS did not hire a third-party contractor to

draft the Hog HIMP Report because the model and the resulting

inspection data had already been reviewed by third-party

contractors. As FSIS explained in the proposed rule, the

independent consulting firm, Research Triangle Institute (RTI),

collected baseline organoleptic and microbiological data in the

five market hog slaughter establishments that volunteered to

participate in the HIMP pilot study before they implemented HIMP

(83 FR 4780, 4788). These baseline data reflect the performance

of these five establishments under traditional inspection before

they implemented HIMP and provided the basis to establish HIMP

performance standards for food safety defects and non-food

safety “Other Consumer Protection” (OCP) defects.

FSIS also explained in the final rule to modernize poultry

slaughter inspection (79 FR 49566, 49573) that in 2002, the

Agency contracted with a third-party technical review team

(review team, henceforth) selected by the National Alliance for

Food Safety to review and evaluate the data collected from young

chicken establishments operating under HIMP. The review team

focused on the validity of the HIMP pilot study design and

method to determine whether FSIS could use the organoleptic and


37

microbial data collected under HIMP to compare the performance

of establishments operating under HIMP to the performance of

establishments operating under non-HIMP inspection systems.

Overall, the review team found that the HIMP study design and

method were valid and provided a useful and legitimate

comparison of the performance of establishments operating under

HIMP and non-HIMP inspection systems. The review team's findings

are described in the report titled Review of the HACCP-Based

Inspection Models Project by the National Alliance for Food

Safety Technical Team (The Hargis Report).16 While the review

team did not review data collected from the market hog

establishments operating under HIMP, the poultry and market hog

HIMP models and the resulting inspection data are very similar.

Therefore, FSIS determined there would be no benefit in hiring

another review team to evaluate the HIMP market hog inspection

data.

Comment: A few consumer advocacy organizations stated that

the data used in the Hog HIMP Report is now stale as the Agency

analyzed data from CY2006 through CY2010 and then CY2012 through

CY2013.

Response: FSIS disagrees. FSIS has not made any significant

changes to the HIMP model since 2013, and FSIS inspectors are

16 The Hargis Report is available at https://www.fsis.usda.gov/OPPDE/nacmpi/Nov2002/Papers/NAFS97.pdf.


38

still performing the same inspection tasks. The Hog HIMP Report

findings from CY2006 through CY2010 and CY2012 through CY2013

were very similar. This shows that not much changed over a

seven-year period, and that the model is stable. No significant

changes in swine slaughter, FSIS inspection, or related

regulations have occurred since CY 2013. Therefore, FSIS has no

reason to believe that the data in the Hog HIMP Report is no

longer useful simply because of the passage of time.

Comment: One consumer advocacy group noted that the Hog HIMP

Report shows that there was an increase in total offline

verification tasks in HIMP establishments during CY2012 and

CY2013. However, according to the same commenter, tables 3-2 and

3-3 in the Hog HIMP Report show that inspectors performed fewer

verification tasks in HIMP establishments than they did in non-

HIMP establishments for more than half of the PHRs in CY2012 and

CY2013. According to the commenter, the Agency treats a total

pooled increase in inspection tasks across all regulations as

outweighing the decreases in some inspection tasks. The

commenter argued that FSIS needs to justify why a decrease in

any inspection task for any regulation will not be detrimental

to food safety. The commenter further argued that FSIS did not

explain why the PHRs are relevant.

Another consumer advocacy group complained that the Hog

HIMP Report did not indicate which inspection tasks were


39

scheduled or unscheduled. The same commenter stated that FSIS

did not demonstrate that the increased offline verification

tasks in HIMP establishments were statistically significant, as

opposed to a product of chance.

Response: The Agency uses PHIS to assign scheduled or

“routine” inspection tasks. Inspectors in large, high-volume

market hog slaughter establishments receive the same number of

routine inspection tasks in both HIMP and traditional

establishments. Unscheduled or “directed” inspection tasks are

initiated by the inspector or their supervisor.

The Hog HIMP Report was not generated to evaluate the

benefits of performing more scheduled versus unscheduled offline

inspection verification tasks. The risk assessment discussed

above evaluated, among other things, the effect of increased

offline inspection verification tasks in swine slaughter

establishments. The objective of the Hog HIMP Report was to

determine whether the HIMP inspection system performs as well as

the traditional inspection system in terms of product safety and

wholesomeness, and overall consumer protection. As FSIS

explained in the proposed rule (83 FR 4780, 4790), the Hog HIMP

Report found that inspectors at HIMP market hog establishments

are performing more off-line food safety related inspection

verification tasks than inspectors at traditional market hog

establishments, including an increased level of Sanitation SOP


40

and HACCP inspection verification tasks. The Hog HIMP Report

also found that HIMP market hog establishments have higher

compliance rates with Sanitation SOP and HACCP regulations,

lower levels of non-food safety defects, equivalent or better

Salmonella verification testing positive rates, and lower levels

of violative chemical residues, as compared to traditional non-

HIMP market hog establishments.

FSIS disagrees that the Agency needed to indicate which

offline inspection verification tasks were scheduled and

unscheduled or demonstrate that the increased number of offline

verification tasks in HIMP establishments were statistically

significant and could therefore be used to evaluate whether HIMP

market hog establishments performed as well as traditional

market hog establishments. FSIS explained in the Hog HIMP Report

that inspectors conducted more offline inspection tasks in HIMP

establishments largely due to the increased inspection for

visible fecal material, ingesta, and milk contamination under 9

CFR 310.18. FSIS inspectors at hog HIMP establishments inspect a

sample of 24 carcasses when they perform a Zero Tolerance

verification task specifically for 9 CFR 310.18, whereas FSIS

inspectors at traditional market hog establishments inspect a

sample of 11 carcasses. These Zero Tolerance verification tasks

are required every shift.


41

Tables 3-2 and 3-3 in the Hog HIMP Report show the number

of times that FSIS inspectors verified compliance with a

regulation. These tables do not necessarily show the number of

times a task was performed. FSIS inspectors verify whether

establishments meet requirements in 9 CFR part 417 when they

conduct HACCP tasks; whether establishments meet requirements in

9 CFR 416.1-6 when they conduct sanitation performance standards

(SPS) tasks; and whether establishments meet requirements in 9

CFR 416.11-17 when they conduct Sanitation SOP tasks. And, while

inspectors receive the same routine tasks, not every regulation

in tables 3-2 and 3-3 needs to be verified in every

establishment. For example, FSIS inspectors would only verify

whether establishments meet requirements in 9 CFR 416.16(b) if

the establishment maintains records on a computer. In addition,

inspectors would only check 9 CFR 417.3(a)-(c) in PHIS if they

were verifying whether establishments met corrective action

requirements after a deviation. So, the fact that table 3-2 and

3-3 show that FSIS inspectors verified fewer 9 CFR part 417

regulations in HIMP establishments does not mean that FSIS

performed fewer HACCP inspection verification tasks in CY2012

and CY2013. Rather, it could mean that inspectors found fewer

deviations that required the subsequent verification of

corrective actions. Therefore, tables 3-2 and 3-3 do not support

the commenter’s argument that FSIS conducted fewer tasks in HIMP


42

establishments, which they claimed could be detrimental to food

safety.

As FSIS explained in the proposed rule (83 FR 4789) and

above, the PHR list is relevant because it consists of

regulations that have higher rates of noncompliance three months

before a pathogen positive or enforcement action. The PHR list

allows FSIS to focus on specific health related provisions of

regulations that may be the most informative for prioritizing

PHREs and FSAs. FSIS compared the number of verifications of PHR

regulations in HIMP and traditional establishments because non-

compliance with these regulations was determined by OPARM to be

an important indicator of subsequent food safety issues and loss

of process control.

Comment: One consumer advocacy group argued that the

increased offline regulation verifications under HIMP are

probably the result of greater reporting, rather than an actual

increase in verifications. The commenter stated that they have

received information that inspectors find that entering data

into PHIS is cumbersome, so they do not enter data for

unscheduled tasks unless they find problems. According to the

commenter, there has been a significant drop in the number of

verification tasks performed since the implementation of PHIS.

Response: FSIS inspectors in both HIMP and non-HIMP

establishments use PHIS. FSIS provides instructions on how to


43

use PHIS in its directives and notices. As FSIS explained above,

an inspector at a large, high-volume slaughter establishment

operating under HIMP would receive the same tasks as an

inspector at a large, high-volume slaughter establishment

operating under traditional inspection, except that the

inspector in the HIMP establishment is instructed to schedule

more carcass verification tasks. The documentation requirements

for inspectors are also the same for HIMP and non-HIMP

establishments. The key difference is that FSIS inspectors in

HIMP establishments routinely document fewer condemned animals,

carcasses, and parts because establishments conduct sorting

procedures before FSIS inspection. Additionally, comments on

inspectors not wanting to document completion of tasks in PHIS

are outside the scope of these regulations.

Comment: A few consumer advocacy groups stated that they

found 32 instances in which establishments were cited for

violating 9 CFR 311.16(a) – Carcasses So Infected that

Consumption of the Meat May Cause Food Poisoning. According to

the commenters, these instances occurred in HIMP establishments

rather than establishments operating under traditional

inspection because establishment sorters on the slaughter line

presented carcasses to FSIS that were unfit for processing. The

commenters argued that the Hog HIMP Report should have compared

NRs for 9 CFR 311.16(a) in HIMP and traditional establishments.


44

One consumer advocacy group noted that the Hog HIMP Report

shows that there were statistically significant differences in

the weighted, health-related Sanitation SOP and HACCP NRs for

the five Hog HIMP establishments as compared to those

establishments operating under traditional inspection for a

combined four years. The commenter noted that while the Agency

indicated in tables 3-9 and 3-10 that the total NRs for

Sanitation SOP and HACCP PHRs were lower in CY2012 and CY2013

for the 5 HIMP establishments, these establishments had more NRs

for non-compliance with other regulations. The commenter argued

that for certain regulations like 9 CFR 417.3(a)(2), the five

HIMP establishments had higher and statistically significant NRs

compared to the 21 comparable non-HIMP traditional

establishments. The commenter stated that the five HIMP

establishments had an 11-fold and three-fold higher rate of

violating 9 CFR 417.3(a)(2) in CY2012 and CY2013, respectively.

The commenter noted that 9 CFR 417.3(a)(2) is a measure of

whether an establishment is maintaining control over a critical

control point. The commenter argued that because the five HIMP

establishments received more NRs for this regulation, they were

not adhering to their HACCP plans, and were out of control more

frequently than the 21 comparable non-HIMP traditional

establishments.


45

The same consumer advocacy group stated that they conducted

their own analysis of NRs issued in the five HIMP establishments

and five comparably-sized non-HIMP traditional establishments

from CY2012 to CY2016. The commenter noted that, based on their

own analysis, the five HIMP establishments had more NRs for non-

compliance with 9 CFR 310.18, 416.3 – 5, 416.13, and 417.2. The

commenter highlighted an NR that was issued to a HIMP

establishment in 2017 because an establishment sorter did not

identify a carcass with a food safety defect. The commenter also

noted that OIG found that from FY 2008 to 2011, three of the 10

swine slaughter establishments cited with the most noncompliance

records (NRs) were HIMP establishments. The commenter argued

that these NRs demonstrate that the HIMP inspection system is

not as effective as the traditional inspection system.

Response: FSIS disagrees that these NRs prove that HIMP

establishments lose process control more often than traditional

establishments. In Table 3-9 in the Hog HIMP Report,17 PHR

noncompliance rates in CY2012 at the five HIMP market hog

establishments were statistically significantly higher for four

regulations, statistically significantly lower for five

regulations, and not statistically significantly different for

eighteen regulations. Overall, the CY2012 PHR noncompliance rate

17 https://www.fsis.usda.gov/wps/wcm/connect/f7be3e74-552f-4239-ac4c-59a024fd0ec2/Evaluation-HIMP-Market-Hogs.pdf?MOD=AJPERES.


46

for Sanitation SOP and HACCP regulations (9 CFR parts 416 and

417) in the five HIMP market hog establishments was

statistically significantly lower than that for the 21

comparison non-HIMP market hog establishments. In Table 3-10 in

the Hog HIMP Report, PHR noncompliance rates in CY2013 at HIMP

market hog establishments were statistically significantly

higher for three regulations, statistically significantly lower

for five regulations, and not statistically significantly

different for nineteen regulations. Overall, the PHR

noncompliance rate in CY2013 for Sanitation SOP and HACCP

regulations in the five HIMP market hog establishments was

statistically significantly lower than that for the 21

comparison non-HIMP market hog establishments. The Sanitation

SOP and HACCP regulations are among the regulations most

strongly related to public health.

Under HIMP, if an establishment does not adequately sort

for carcasses showing signs of septicemia or pyemia, FSIS issues

an NR for 9 CFR 311.16(a). FSIS does not issue NRs for this

regulation under traditional inspection because FSIS inspectors

are responsible for identifying and removing food safety and

non-food safety defects.

As is explained above, under HIMP, FSIS inspectors inspect

a sample of 24 carcasses when they perform a Zero Tolerance

verification task as opposed to inspecting a sample of 11


47

carcasses under traditional inspection. In addition, the

Agency’s offline inspectors in HIMP establishments perform more

offline inspection activities that FSIS has concluded are more

effective in ensuring food safety than offline FSIS inspectors

perform in non-HIMP establishments operating under the

traditional inspection system. Therefore, FSIS inspectors in

HIMP establishments have more opportunities for detecting

noncompliance with regulatory requirements that are directly

related to public health than inspectors do in non-HIMP

traditional establishments.

Comment: Several commenters argued that until FSIS can

compare and evaluate HIMP and non-HIMP establishment performance

using compatible data, the same data reporting period, and an

equal number of establishments, and show a marked superiority of

HIMP establishment performance, FSIS must not finalize the

proposed rule.

Response: FSIS maintains that the data collected during the

HIMP pilot study was valuable for evaluating whether the HIMP

inspection system performs as well as the traditional inspection

system. As stated above, FSIS did compare data from the same

reporting periods and compared establishments with similar HACCP

size and production volume. As stated in the Hargis report,

“[t]he review team noted some issues related to optimal design

and interpretation, but finds that overall the data collected


48

were both meaningful and useful and that the study was designed

and conducted under real-world conditions and limitations.” The

review team also concluded that “the overall design and

methodology . . . were perhaps the best available options to

allow for comparison of organoleptic data between the

traditional and HIMP systems.” FSIS disagrees that the Agency

needs to show that the HIMP system is superior to the

traditional inspection system before it can finalize the

proposed rule.

C. Risk Assessment

Comment: The risk assessment used FSIS microbiological

testing and inspection data from 2010 – 2011 and data from the

HIMP pilot study. A few consumer advocacy organizations and

public health organizations argued that the data has the

following problems: 1) the data is generated through regulatory

programs designed to verify process control within a given

establishment at a specific point in time; 2) the data is at

least seven years old and may not be representative of current

industry practices, and 3) there were only five market hog

slaughter establishments that volunteered and agreed to meet the

additional requirements in the HIMP pilot study, resulting in a

biased sample and results that are not generalizable to all non-

HIMP market hog slaughter establishments.


49

Response: For purposes of the risk assessment, data from

HIMP establishments were combined with data from traditional

establishments to get a more complete picture of the possible

combinations of establishment characteristics, inspection

procedures, and Salmonella prevalence. The assessment produced

estimates of Salmonella illnesses under scenarios where

inspectors perform more offline food safety activities as

compared to traditional inspection. As FSIS explained above, the

data FSIS used in the Hog HIMP Report and risk assessment are

still useful, despite the passage of time, because the HIMP

inspection model has not changed since 2013 and FSIS is still

conducting the same inspection procedures. FSIS also explained

above that the Agency does not believe that the results are

biased because there is evidence that the volunteer

establishments participating in the HIMP pilot study are typical

of the broader industry.

Comment: One public health organization stated that the

model predicts that maximum reduction in the percentage of

Salmonella positive samples and market hog-attributable

salmonellosis cases occurs when the average numbers of offline

inspection procedures performed (Scheduled and Performed (SP)

and Unscheduled (U)) increase 25 percent and the numbers of

Scheduled but Not Performed (SNP) and NR inspection procedures

decrease 50 percent and 46.67 percent, respectively. The


50

commenter also stated that FSIS concluded that all

establishments under NSIS are expected to achieve greater

process control in response to increases in FSIS offline

inspection tasks in addition to industry-wide commercial and

technological innovation that will likely occur over time.

According to the commenter, these results assume that resources

will be re-allocated within an establishment in such a way that

the FSIS offline inspection resources increase by 25 percent and

the number of scheduled but not performed FSIS tasks decreases

by 50 percent. The commenter questioned if this is achievable

given FSIS’s current inspection resources. The commenter stated

that if inspection resources are lost, through attrition or

budget cuts, these assumptions may not be realistic.

Response: The predicted increase in offline inspection

resources and decrease in scheduled but not performed activities

are achievable with FSIS’s current inspection resources. In

fact, NSIS will allow FSIS to better use its inspection

resources. FSIS discusses the impact of attrition and budget in

more detail in section “I. Potential Budgetary Impacts on the

Agency.”

Comment: One consumer advocacy organization stated that the

risk assessment shows that the five HIMP establishments had

higher NRs (9.4-times more, when weighted by volume) than the

non-HIMP traditional establishments. According to the commenter,


51

the risk assessment also shows that NRs are the strongest and a

statistically significant indicator of human illnesses related

to consuming contaminated pork.

The same commenter stated that decreasing NRs in all market

hog establishments would have the effect of reducing illnesses

by 3,893, or 4.7 percent. The commenter argued that this

reduction would be 1.5 times greater than the reduction FSIS

expects will be possible (2,533) by increasing offline

verification tasks under NSIS. According to this organization’s

analysis, FSIS would reduce more illnesses by decreasing NRs,

compared to redeploying inspection resources under NSIS.

Response: As FSIS explained in the risk assessment, NRs

were included in this assessment for theoretical evaluation only

as a possible decision variable because of inclusion in the NPIS

risk assessment. For this assessment, the variables associated

with offline inspection tasks represent the sum of each type of

category across the various inspection procedure codes in an

establishment on each day that a Salmonella sample was

collected. Unlike SP, SNP, and U, NRs depend on noncompliance by

establishments and are strictly not an FSIS decision variable.

Historic occurrences of establishment non-compliance may help

explain variability in pathogen performance that already has

been observed. However, because future NR rates depend on the

behavior of establishments, it is not feasible to assume that


52

the NR rates can be varied (like SP, SNP, and U) solely by

reallocating Agency inspection resources. Therefore, FSIS

considers implementation scenarios that simulate future changes

in the NR variable infeasible, but the theoretical examination

of NRs offers potential risk management insights.

Comment: A consumer advocacy organization asked, if

conducting more offline procedures at HIMP establishments

reduces Salmonella contamination, why didn’t FSIS find a

statistically significant reduction in Salmonella in HIMP

establishments as compared to non-HIMP traditional

establishments? The commenter noted that from CY2006 through

CY2009 the Salmonella percent positive for market hogs was lower

in HIMP establishments than in non-HIMP establishments, but it

was higher in the HIMP establishments in CY2010. According to

the commenter, data from a baseline Salmonella study from August

2010 through August 2011 found that the Salmonella percent

positive for carcasses in the HIMP establishments was almost

one-half the value of the rate in comparable non-HIMP

establishments — 0.69 percent and 1.35 percent, respectively –

but the difference was not statistically significant. According

to the commenter, FSIS did not explain why the Salmonella

percent positive for carcasses are sometimes higher in HIMP

establishments and sometimes lower as compared to non-HIMP

establishments.


53

Response: The risk assessment was not conducted as a

comparison between HIMP and non-HIMP establishments operating

under traditional inspection. It was a regression analysis that

looked at the numbers of FSIS inspection procedures conducted

and Salmonella prevalence at all swine slaughter establishments

together. The risk assessment did show a statistically

significant relationship between increased offline inspection

procedures and reduced Salmonella contamination for carcasses.

In contrast, the Hog HIMP Report compared the average Salmonella

percent positive between the five HIMP establishments and

twenty-one non-HIMP comparison establishments. The latter

analysis did not detect statistically significant differences

between these two establishment groups across years, and this is

likely attributable to the small sample size (number of HIMP and

non-HIMP establishments) relative to the low number of

Salmonella percent positives at the post-chill carcass sampling

point.

Comment: A few consumer advocacy organizations and public

health organizations noted that the risk assessment that

informed the modernization of poultry slaughter inspection final

rule also predicted that conducting more offline tasks would

likely result in food safety benefits. According to the

commenters, microbial sampling conducted since NPIS’s

implementation has not supported this prediction. A few


54

commenters noted that in a preliminary assessment of NPIS

provided to stakeholders last fall, FSIS indicated that

Salmonella and Campylobacter percent positives were similar

between large establishments that volunteered to operate under

NPIS and large establishments that decided not to change their

inspection systems. One consumer advocacy organization argued

that recent data reveal that NPIS establishments are more likely

to fail FSIS Salmonella performance standards than

establishments that have not converted to NPIS. The commenters

argued that like NPIS, NSIS will not have food safety benefits.

Response: As noted by the commenters, in a preliminary

assessment of NPIS, FSIS found that carcass Salmonella and

Campylobacter percent positives for the group of establishments

that had converted to NPIS were comparable to those for similar

establishments that had not converted to NPIS.18 This assessment

included all establishments that had converted to NPIS at that

point in time, including the former HIMP establishments. The

assessment also found that the former HIMP establishments had

lower carcass Salmonella percent positives than both non-NPIS

establishments and non-HIMP NPIS establishments, suggesting that

carcass Salmonella percent positives are lower in establishments

18 Update on Preliminary Analysis of Modernization of Poultry Slaughter, October 2017 available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/himp-study-plans-resources/poultry-slaughter-inspection.


55

with more experience operating under HIMP and NPIS inspection

systems. The Agency will continue to track FSIS carcass

Salmonella percent positives as more establishments convert to

NPIS.

The October 2017 preliminary analysis mentioned by the

commenters compared 39 large NPIS establishments, 23 of which

were former HIMP establishments, to 126 large non-HIMP and non-

NPIS establishments. Poultry establishments continue to convert

to NPIS, allowing for a more meaningful comparison between NPIS

and non-NPIS establishments. FSIS analyzed the data and found no

statistically significant difference in the proportion of

establishments that fail to meet carcass Salmonella performance

standards between those operating under NPIS and those operating

under the traditional inspection system. Considering

uncertainty, the 95 percent confidence interval for the

difference in proportions includes zero. This provides

supporting empirical evidence independent of the risk assessment

model that in practice the NPIS provides an equivalent level of

food safety protection compared to traditional inspection. FSIS

disagrees that the current data shows that there will be no food

safety benefits related to NPIS, and therefore, there will be no

food safety benefits related to NSIS. Especially since the

October 2017 preliminary analysis found that FSIS inspectors are

performing approximately four times more offline verification


56

tasks for visible contamination in NPIS establishments than in

non-NPIS establishments. FSIS will continue to evaluate the

public health impact associated with NPIS as more establishments

convert and experience is gained with operating under NPIS.

Comment: One consumer advocacy organization noted that

FSIS’s uncertainty analysis indicated that there is a 12.5

percent chance that there will be increased illnesses simply by

increasing the number of scheduled-performed verification tasks.

The commenter argued that FSIS should not finalize a rule that

would not improve public health.

Response: The risk assessment analyzed data on specific

types of inspection activities and the prevalence of Salmonella

in market hog slaughter establishments. The results suggest

that, because inspection personnel assigned to NSIS will conduct

more of the type of inspection activities that were correlated

with lower Salmonella prevalence, NSIS will potentially result

in fewer human illnesses than would be expected if not

implemented. Therefore, FSIS needs to publish and implement

this rule to be able to shift resources and realize the

predicted benefits. In addition to the estimated values, the

analysis provides the statistical uncertainty of the estimated

number of averted illnesses by reporting the upper and lower

confidence bounds around the estimates to acknowledge that

uncertainty always will exist in such models.


57

Comment: One public health organization stated that FSIS

did not assess the public health impact of increasing

establishments’ line speeds in the proposed rule. The same

commenter stated that FSIS should explore the public health

impact of increasing line speeds before finalizing the proposed

rule.

Response: While the relationship between line speed and

Salmonella prevalence was not incorporated into the risk

assessment model, FSIS did consider the impact of line speed on

HIMP establishment performance in the Hog HIMP Report. The Hog

HIMP Report estimated that in CY2013, line speeds at the 5 HIMP

market hog establishments varied from 885 to 1,295 head per hour

(hph), with an estimated average line speed of 1,099 hph. The 21

non-HIMP comparison establishments had estimated line speeds of

571 to 1,149 hph, with an estimated average line speed of 977

hph. The Hog HIMP Report found that even with slightly faster

line speeds, HIMP market hog establishments had higher

compliance with Sanitation SOP and HACCP regulations, lower

levels of non-food safety defects, equivalent or better

Salmonella verification testing positive rates than the 21

traditional non-HIMP comparison market hog establishments, and

lower levels of violative chemical residues.

Comment: A few commenters urged the Agency to redo the risk

analysis model using data from FSIS’s Salmonella pork cuts and


58

comminuted pork exploratory testing after that project has been

finalized.

Response: Data from the Agency’s pork cuts and comminuted

pork exploratory testing project would not improve the risk

assessment. While the pork parts data may prove useful for

monitoring and evaluating process control during further

processing, it will not be useful for measuring process control

during slaughter operations. Processing establishments purchase

primals from multiple slaughter establishments. Because

establishments comingle primals during processing, they may

become contaminated during processing. As a result, the

Salmonella percent positives during processing would not be

reflective of Salmonella percent positives or pathogen

contamination at the end of slaughter operations.

Comment: One animal welfare group argued that the risk

assessment and peer review were too narrow in scope. The

commenter argued that the risk assessment should not have been

limited to Salmonella risk but should have included every

potential food safety and public health risk. The commenter was

especially concerned about the risk of Yersinia enterocolitica

and influenza.

Response: FSIS selected Salmonella because it is the most

common cause of foodborne illness associated with pork products

and interventions targeted at reducing Salmonella have been


59

shown to be effective at reducing contamination by other enteric

pathogens, such as Yersinia enterocolitica. FSIS did not include

swine influenza in the Agency’s risk assessment because swine

influenza has not been shown to be transmissible to people

through eating pork products.

Comment: One consumer advocacy organization commented that

FSIS had not adequately considered the peer review comments and

cited Reviewer E’s comment about whether using simulated data is

“a statistically legitimate approach.”

Response: After additional internal review, FSIS has

decided to add language to the risk assessment to highlight the

results of the modeling without simulated data (see Table 13 in

the risk assessment). FSIS is confident that it has addressed

reviewers’ comments on the risk assessment.

D. NSIS

Comment: Comments from swine slaughter establishments,

trade associations representing the pork industry, and a few

private citizens supported the proposed rule. These comments

stated that NSIS will enhance FSIS inspection procedures and

increase industry efficiency while ensuring safeguards are in

place to promote worker safety and animal welfare.

However, comments from consumer advocacy organizations,

labor unions, public health organizations, animal welfare

advocacy organizations, worker rights advocacy organizations,


60

and private citizens objected to NSIS for various reasons. Many

of these commenters objected to NSIS because they view NSIS as a

system that “privatizes” inspection by replacing FSIS inspectors

with establishment employees.

Response: FSIS is not privatizing swine slaughter

inspection. The new inspection system will not eliminate FSIS

inspection. NSIS simply requires establishments to take

additional steps before FSIS inspection to ensure that their

products are safe and wholesome.

As FSIS explained in the proposed rule, most market hog

establishments under traditional inspection already voluntarily

conduct sorting activities before FSIS ante-mortem inspection

(83 FR 4780, 4783). Under NSIS, because establishment employees

are responsible for identifying and removing market hogs that

are not fit for slaughter before FSIS ante-mortem inspection,

FSIS inspectors are presented with healthier animals that are

more likely to pass inspection. Under NSIS, FSIS will continue

to conduct ante-mortem inspection. The key difference is that

establishment sorting activities will be mandatory.

Under traditional inspection, establishments conduct no

post-mortem carcass sorting to identify which carcasses and

parts appear eligible to bear the mark of inspection, which

carcasses and parts contain removable defects correctable

through trimming, and which carcasses and parts should be


61

submitted to FSIS for condemnation because of generalized

diseases or conditions. Rather, under traditional inspection,

establishments are required to assign competent assistants to

take such actions as directed by FSIS online inspectors after

the inspectors have conducted the initial inspection activities

(see 9 CFR 307.2(g)). Therefore, under traditional inspection,

establishments rely on FSIS online inspectors to effectively

control and direct their processing.

Under NSIS, FSIS inspectors will still be stationed on the

evisceration line and these inspectors will continue to inspect

every head, viscera, and carcass as required by the FMIA. FSIS

offline inspectors will also continue to conduct food safety

related inspection activities and evaluate establishment process

controls. However, FSIS will require establishments operating

under NSIS to take a more proactive role in removing

contamination and identifying defects before FSIS post-mortem

inspection.

Comment: A few consumer advocacy groups argued that the

proposed rule’s ante-mortem condemnation provisions violate the

FMIA. One consumer advocacy group stated that 21 U.S.C. 603 and

9 CFR 301.9(a) require FSIS inspectors to examine and inspect

each animal before it can be slaughtered for human food. The

consumer advocacy group argued that FSIS completely disregards

this requirement by allowing establishment employees to “bypass”


62

antemortem inspection for 90 to 95 percent of all moving animals

not deemed suspect by the establishment.

Several commenters noted that a former chief veterinarian

for FSIS spoke out against the ante-mortem portion of the

proposal, suggesting that it would increase the risk that FSIS

veterinarians could miss the early signs of a large-scale animal

disease outbreak. The commenters stated that an outbreak could

impact food safety while having devastating economic

consequences for U.S. animal producers. According to the

commenters, a large outbreak of Foot and Mouth Disease (FMD) has

the potential to shut off all foreign markets to U.S. beef and

pork, costing American producers an estimated $128 billion over

a 10-year period.

Two foreign countries requested clarification on the role

of the FSIS Public Health Veterinarian (PHV) and inspectors in

the context of ante-mortem activities under the NSIS. The

commenters questioned if FSIS inspectors or veterinarians will

inspect all animals or carcasses removed by the establishment

sorters.

Response: As FSIS explained in the proposed rule, animal

sorting procedures under HIMP and NSIS are virtually the same as

animal segregation procedures used voluntarily by most market

hog establishments under traditional inspection. FSIS has

allowed establishments operating under traditional inspection to


63

voluntarily implement animal segregation procedures since at

least the 1980s without adverse economic consequences.

Most establishments under traditional inspection that

slaughter only market hogs voluntarily segregate animals that

show signs of diseases or conditions from healthy animals before

the Agency performs ante-mortem inspection.19 Therefore, market

hog establishment personnel segregate animals that appear to be

normal and healthy from abnormal or unhealthy animals that

appear to have condemnable diseases or conditions (e.g., animals

exhibiting signs of neurologic conditions, pyrexia, or severe

lameness) into “subject” pens, where they undergo additional

FSIS inspection. FSIS requires these establishments to document

their segregation procedures in their HACCP plans or

prerequisite programs.20 FSIS inspectors examine all animals

found by the establishment to be normal at rest, and five to ten

percent of those animals in motion.21

FSIS disagrees that this inspection scheme violates the

FMIA. FSIS inspectors still conduct 100 percent ante-mortem

19 See FSIS Directive 6100.1, Ante-mortem Livestock Inspection available at http://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES. 20 See FSIS Directive 6100.1, Ante-mortem Livestock Inspection available at http://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES. 21 See FSIS Directive 6100.1, Ante-mortem Livestock Inspection available at http://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES.


64

inspection.22 If any animals exhibit signs of condemnable

conditions, FSIS inspectors direct establishment employees to

move the animals to the “U.S. Suspect” pens for final

disposition by the FSIS PHV. The FSIS PHV examines all animals

in the “subject” and “U.S. Suspect” pens. FSIS inspectors

observe establishment employees performing animal segregation

procedures at least once per month.

As mentioned above, the key difference, as compared to

traditional inspection, is that sorting procedures are mandatory

under NSIS. All establishments operating under the NSIS must

address, as part of their HACCP system, procedures for sorting

animals showing signs of diseases or abnormalities from healthy

animals. These procedures must cover establishment sorting

activities for dead and moribund swine and swine suspected of

having central nervous system (CNS) conditions or pyrexia.

Establishments under NSIS that do not adequately sort for these

food safety defects before FSIS ante-mortem inspection will

receive an NR for noncompliance with 9 CFR 309.19.

Regarding the questions from the foreign countries, FSIS

inspectors inspect every market hog offered for slaughter.

However, an establishment may decide to divert hogs that do not

22 See FSIS Directive 6100.1, Ante-mortem Livestock Inspection available at http://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES.


65

meet its market specifications to another slaughter facility,

where they will receive 100 percent ante-mortem inspection by an

FSIS inspector. This is not a change in policy. Establishments

operating under traditional inspection may also divert hogs to

other establishments operating under traditional inspection. If

establishments decide to divert hogs, they are required to

follow the Animal and Plant Health Inspection Service’s

(APHIS’s) regulations governing the movement of live animals.

Under the NSIS, FSIS inspectors will observe establishment

employees performing sorting procedures. During this time, FSIS

inspectors will verify that animals that are intended to be

disposed of are humanely euthanized and that animals that are

intended to be diverted to another official establishment are

eligible for transport.

Comment: Several comments asserted that revoking maximum

line speeds conflicts with the purposes or provisions of the

FMIA because faster line speeds will make it more difficult for

FSIS inspectors to effectively conduct online inspection. A

consumer advocacy organization stated that the FSIS inspectors

must provide a “critical appraisal” of all carcasses (AFGE v.

Glickman, 215 F.3d 7, 11 (D.C. Cir. 2000)). According to the

comments, revoking maximum line speeds will make it extremely

difficult, if not impossible, for FSIS to conduct a critical

appraisal of each hog.


66

Comments from consumer advocacy organizations and an animal

welfare organization further argued that FSIS does not have the

statutory authority to conduct rulemaking to increase

efficiencies for the government and industry.

Response: Based on FSIS’s experiences under HIMP, online

inspectors in HIMP establishments can conduct an effective

online inspection of the head, viscera, and carcass of each hog

when operating at faster line speeds. To ensure that online

inspectors will be able to conduct effective online inspections,

FSIS PHVs in all NSIS establishments are authorized to direct

establishments to operate at reduced line speeds when, in the

PHV’s judgment, a carcass-by-carcass inspection cannot be

performed within the time available due to the way that the hogs

are presented to online inspectors, or because the establishment

is not maintaining process control (9 CFR 310.26).

FSIS has the authority to change its regulations to conduct

more efficient inspections and to reduce unnecessary regulatory

burdens on industry. As FSIS explained in the proposed rule (83

FR 4780, 4782), 21 U.S.C. 621 provides that the Secretary shall

make such rules and regulations as are necessary for the

efficient execution of the provisions of the FMIA. In addition,

this rulemaking is consistent with E.O. 13563, which directs

Federal agencies to review existing rules that may be


67

burdensome, unnecessary, and outdated and to modify, streamline,

expand, or repeal them accordingly.

Comment: Several comments from consumer advocacy

organizations, public health organizations, worker advocacy

organizations, labor unions, and private citizens objected to

FSIS’s requirement that establishment employees sort carcasses

and parts before they are presented for FSIS inspection because

the commenters believe that establishment employees will miss

many food safety and OCP defects. A few commenters referenced

affidavits from three FSIS inspectors who worked in HIMP

establishments who stated that because of excessive line speeds

and lack of training, establishment sorters routinely miss many

food safety and wholesomeness defects. The commenters argued

that FSIS must more thoroughly evaluate the proposal to allow

establishment employees to perform preliminary sorting before

the Agency implements NSIS.

Response: The Hog HIMP Report found that the overall

performance of HIMP establishments was as good as non-HIMP

establishments. Results from offline inspections in HIMP

establishments, which are conducted after establishment

employees have completed the initial sorting of carcasses and

parts, show that the rates of carcasses with food safety defects

(e.g., septicemia, toxemia, pyemia, and cysticercosis) and

visible contamination from visible fecal material, ingesta, and


68

milk in HIMP establishments were very low, well below the levels

set by the HIMP performance standards. In addition, as explained

in the proposed rule, OCP defect rates identified on carcasses

and parts in HIMP establishments average about half the

corresponding OCP HIMP performance standard. Therefore, the data

from the HIMP pilot study show that establishment employees do

effectively sort carcasses, trim defects, and identify carcasses

for disposal before FSIS post mortem inspection.

Comment: Several consumer advocacy groups and a public

health organization recommended that FSIS establish training for

establishment employees performing sorting activities and

require sorters to prove proficiency in performing their duties.

Members of industry stated that establishments operating

under HIMP have been successful at training employees to sort

for food safety and non-food safety defects. These commenters

commended the Agency for creating its sorter guide. The

commenters stated that the sorter guide is comprehensive and

consistent with current practices under HIMP. However, the

commenters stated that the sorter guide could be improved by

defining several pathological conditions and veterinary terms

not well-known to industry personnel, as well as updating photos

and diagrams.

Response: FSIS is not prescribing specific sorter training

or certification. FSIS made some editorial changes to its sorter


69

guide to simplify the guideline. The Agency did not make any

significant changes to its sorter guide in response to comments.

FSIS did not think it was necessary to add the pathological

conditions, veterinary terms, or pictures mentioned in the

comments because they are not commonly found or used. However,

FSIS PHVs will be available to discuss conditions and terms if

an establishment has any questions. The guide is available on

the FSIS Web site at:

http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatorycompli

ance/compliance-guides-index. As FSIS explained in the proposed

rule, the guide that the Agency has developed is based on the

training that FSIS provides to its online inspection personnel

that are responsible for sorting carcasses under the existing

inspection systems.

Comment: Members of the pork industry and a trade

association representing members of the pork industry requested

that FSIS clarify when NRs will be issued by offline inspectors

for carcasses contaminated with visible fecal material, ingesta

and milk. The commenters noted that the proposed rule stated

that FSIS will issue NRs for every carcass contaminated with

fecal material, ingesta, and milk. According to the commenters,

this policy is not consistent with FSIS Directive 6420.2, which

instructs inspection personnel to issue NRs based on a specific

sampling procedure during carcass verification checks.


70

Response: FSIS is clarifying that, consistent with FSIS

Directive 6420.2, only offline inspectors will issue NRs for

fecal material, ingesta, or milk contamination if they observe

the contamination on sampled carcasses when performing the

Livestock Zero Tolerance Verification task. FSIS online

inspectors will not issue NRs if they observe fecal material,

ingesta, or milk contamination on the carcasses. Rather, online

inspectors will stop the slaughter line to allow for trimming of

the carcass by establishment personnel and reinspection of the

carcass by the inspector, unless the establishment has provided

a rail-out loop. FSIS did not intend to change these inspection

procedures with the implementation of this rule.

Comment: Members of the pork industry and trade

associations representing the pork industry stated that the

proposed requirement to immediately denature carcasses that have

been sorted and removed from slaughter is overly burdensome and

unnecessary. One trade association stated that imposing specific

denaturing requirements may discourage establishments from

adopting NSIS. That commenter suggested that FSIS amend the

proposed 9 CFR 309.19(c) to read “the establishment must dispose

of the carcass according to 9 CFR part 314.” A HIMP

establishment recommended FSIS require that establishments

maintain procedures to control and isolate carcasses and parts

removed from slaughter and demonstrate that they do not enter


71

the human food chain or immediately denature in accordance with

9 CFR part 314.3.

Response: FSIS has considered these comments and believes

they have merit. Therefore, FSIS has revised its proposed

disposal requirements and will instead require establishments to

develop, implement, and maintain written procedures to ensure

that animals and carcasses that have been sorted and removed for

disposal do not enter the human food supply and are properly

disposed of according to 9 CFR part 314.


associations representing members of the pork industry noted

that APHIS uses FSIS animal disposition data, collected and

maintained through PHIS, to monitor animal disease rates and

identify trends. These commenters all agreed that these data are

useful and should not be lost in the transition to NSIS.

According to these commenters, it would not be overly burdensome

for establishments to keep records of the specific reasons why

hogs are removed from slaughter because they already produce

similar records. The commenters recommended that FSIS work with

establishments on a procedure to transfer disposition

information to APHIS on a regular schedule to ensure the ongoing

utility of APHIS’s swine health surveillance programs.

Response: In response to these comments, FSIS has amended

its proposed record keeping regulations to require swine


72

slaughter establishments to maintain records to document the

total number of animals and carcasses sorted and removed per day

and the reasons for their removal. FSIS has created a form to

collect disposition data from establishments. Establishments may

provide the same information as requested on the form

electronically if it is submitted in a format approved by FSIS;

FSIS will provide further instructions on submitting this data

electronically via PHIS later. FSIS will need establishments to

submit their electronic data in a format that is compatible with

PHIS so that the Agency can quickly analyze the data and share

it with APHIS. FSIS has updated its Paperwork Reduction Act

analysis to account for this new requirement.

Comment: Members of the pork industry, trade associations

representing the pork industry, and a foreign country urged the

Agency to allow establishments the discretion to incise lymph

nodes when conducting carcass sorting activities based on their

own hazard analysis. One member of the pork industry stated that

they have demonstrated through testing and a supplier risk

assessment that there is no value in incising lymph nodes to

identify pathological conditions.

The foreign country noted that this approach aligns with

the visual-only inspection methodology already implemented by

other World Trade Organization (WTO) members. According to the

foreign country, on-farm practices (husbandry, biosecurity,


73

etc.) have evolved and improved to a point that disease

transmission risks can be greatly reduced through effective on-

farm controls. The foreign country stated that palpating and

incising the mandibular lymph nodes has been shown to contribute

to cross contamination of pork products by food safety hazards

such as Salmonella and Yersinia. Therefore, the foreign country

argued that moving to a routine visual-only inspection,

supported by supply-chain information from primary production

facilities, would improve food safety systems.

One trade association stated that the administrative hassle

involved in collecting, organizing, and presenting supply-chain

information to FSIS to demonstrate that animal diseases like M.

avium are not reasonably likely to occur would be unnecessarily

arduous and not worth the benefits related to not incising lymph

nodes.

Response: This final rule requires that establishment

sorters incise mandibular lymph nodes and palpate viscera to

detect the presence of animal diseases as part of their sorting

activities, as was proposed (9 CFR 310.26(b)). However,

establishments that operate under NSIS may seek waivers (9 CFR

303.1(h)) under the SIP to 9 CFR 310.26(b). Establishments would

need to submit documentation supporting that the presence of

animal diseases like M. Avium is not reasonably likely to occur.

Should FSIS grant these waivers, establishments would be


74

permitted to decide, on a lot-by-lot basis, whether to incise

mandibular lymph nodes and palpate the viscera to detect the

presence of animal diseases. The Agency has decided to grant

waivers, when appropriate, to gather more information on the

public health impact of such sorting activities to support

potential future rulemaking.

Comment: A foreign country requested clarification on the

requirement (9 CFR 310.26(a)) for establishments with fewer than

three inspection stations to have a mirror at the carcass

inspection station. The commenter questioned whether all NSIS

establishments will have to have mirrors at the carcass

inspection station. The foreign country was concerned that this

requirement will be more burdensome than necessary, particularly

for small establishments operating at slower line speeds.

Response: FSIS is requiring all NSIS establishments to

provide a mirror so that FSIS can adequately inspect carcasses.

Large, high-volume market hog slaughter establishments under

traditional inspection are already required to provide mirrors

to assist FSIS inspection (see 9 CFR 310.1(b)(3) and

307.2(m)(6)).

As FSIS explained in the proposed rule, the Agency does not

expect very small establishments to convert to NSIS because of

the costs of hiring and training establishment sorters.

E. Line Speed


75


associations representing members of the pork industry supported

FSIS’s proposal to revoke maximum line speed limits for

establishments operating under NSIS. Some of these commenters

noted that line speeds were originally established to define the

number of FSIS online inspectors required to inspect carcasses

based on the number of carcasses an individual could reasonably

evaluate in a given period. According to the commenters, when

these limits were set, animal disease prevalence was much

higher, so inspectors needed more time to complete inspection.

The commenters agreed with FSIS’s conclusions that innovations

in animal housing, genetics, and processing have been

implemented and have improved livestock conditions at slaughter;

therefore, the current line speed limits are outdated and

unnecessary.

Members of the pork industry and trade associations

representing the pork industry also stated that revoking maximum

line speeds will allow establishments to better adapt their line

speeds to slaughter conditions. These commenters argued that

line speeds can be adjusted to optimize efficiencies without

jeopardizing worker safety, animal welfare, food safety, or

quality. These commenters noted that the Hog HIMP Report found

that HIMP establishments do not operate at line speeds that are


76

significantly faster than the current maximum line speed for

market hogs.

Response: This final rule revokes the maximum line speeds

for establishments operating under NSIS. The maximum line speed

under the existing regulations for market hogs is 1,106 head per

hour (hph) with seven online inspectors. Experience from the

HIMP pilot study shows that HIMP establishments operate with an

estimated average line speed of 1,099 hph, and that the line

speeds varied from 885 hph to 1,295 hph (under a waiver). Thus,

although they are authorized to do so, market hog HIMP

establishments do not operate at line speeds that are

significantly faster than the current maximum line speeds for

market hog establishments operating under traditional

inspection.

NSIS is informed by the Agency’s experiences under HIMP,

and establishments operating under HIMP have demonstrated that

they are capable of consistently producing safe, wholesome, and

unadulterated pork products while operating at line speeds above

the current maximum line speeds (for market hogs under

traditional inspection). HIMP establishments also have

consistently met pathogen reduction and other performance

standards when operating without prescribed maximum line speeds.

Moreover, NSIS incorporates additional measures that will apply

to all swine slaughter establishments. These measures, which


77

include carcass testing for microbial organisms at pre-

evisceration and post-chill (or for hot-boned product, pre-

evisceration and after the final wash), are designed to ensure

that establishments maintain process control. As a result, FSIS

has decided that line speed limits are not necessary for

establishments operating under NSIS.

Comments: Members of the pork industry and trade

associations representing the pork industry stated that

increased line speeds will not present greater risks for worker

safety. One company that owns a HIMP establishment commented

that they have not found a correlation between line speeds and

worker safety issues in their establishment. According to this

commenter, their company’s Total Recordable Incident Rate (an

OSHA reporting category) has shown a significant decline in

recordable injuries since they started operating under their

line speed waiver. The commenter also stated that their findings

were consistent with the proposed rule’s comparative analysis of

injuries, which found that HIMP establishments had lower mean

injury rates than non-HIMP establishments.

Members of the pork industry and trade associations

representing the pork industry stated that establishments

continuously evaluate worker safety. According to the

commenters, establishments actively work to reduce injuries by

implementing ergonomic programs, modifying processes, and


78

creating additional job positions to distribute manual tasks

among workers.

However, comments from worker advocacy organizations, labor

unions, consumer advocacy organizations, an environmental

advocacy organization, and private citizens asserted that

revoking maximum line speeds will increase risks to worker

health and safety in establishments that operate under NSIS. The

comments referenced studies, reports, and other data on work-

related injuries in the meat processing industry. The most

commonly referenced information sources included:

•Documents published by OSHA that state that

musculoskeletal injuries and disorders are prevalent in the

meatpacking industry. In the documents, OSHA recommends that

establishments should reduce line speeds and production rates to

decrease injury rates.

•2016 BLS data showing that employer reported injury rates

for meat establishment workers who were injured or made ill at

work are 2.4 times the rate of workers in other private-sector

industries.

•Reports published by the GAO that concluded, among other

things, that injury rates in the meat slaughter industry

continue to be higher than the rates for others in the

manufacturing industry, that meat workers may under-report

illnesses and injuries because they fear losing their jobs, and


79

that employers may underreport worker injuries because of

concerns about potential costs.

•Various reports from worker advocacy organizations on

worker safety in meat processing establishments. These reports

include statements from slaughter establishment workers that

have suffered illnesses and injury from the fast-paced

repetitive tasks associated with the current line speeds.

The comments stated that the available studies, reports,

and data contradict FSIS’s analysis of worker illness and injury

in the proposed rule.

Response: While FSIS agrees that safe working conditions in

swine slaughter establishments are important, the Agency has

neither the authority nor the expertise to regulate issues

related to establishment worker safety. FSIS has been delegated

the authority to exercise the functions of the Secretary of

Agriculture under the FMIA, the Poultry Products Inspection Act

(PPIA; 21 U.S.C. 451 et seq.), and the Egg Products Inspection

Act (EPIA; 21 U.S.C 1301 et seq.) (the Acts). Under these Acts,

FSIS protects the public by verifying that meat, poultry, and

egg products are safe, wholesome, not adulterated, and properly

marked, labeled, and packaged. The Acts authorize FSIS to

administer and enforce laws and regulations solely to protect

the health and welfare of consumers.


80

The Department of Labor’s OSHA was created by the

Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et

seq.) to assure safe and healthful working conditions for men

and women by setting and enforcing standards and by providing

training, outreach, education, and assistance. OSHA is the

Federal agency with statutory and regulatory authority to

promote workplace safety and health. FSIS’s authority with

respect to working conditions in slaughter establishments

extends only to FSIS inspection personnel.

FSIS has worked with OSHA to develop a poster that

establishments must display providing information on the signs

and symptoms of occupational injuries and illnesses experienced

by market hog slaughter workers, and about workers' rights to

report these conditions without fear of retaliation (see 9 CFR

310.27). This final rule also requires establishments operating

under NSIS to submit on an annual basis an attestation to the

management member of the local FSIS circuit safety committee

stating that the establishment maintains a program to monitor

and document any work-related conditions of establishment

workers (9 CFR 310.27). Because OSHA is the Federal agency with

statutory and regulatory authority to promote workplace safety

and health, FSIS will forward these annual attestations to OSHA

for use in its own enforcement program. FSIS employees, however,

will not be responsible for determining the merit of the content


81

of the attestation or for enforcement of non-compliance with the

attestation provision. OSHA and FSIS will continue to partner

through a Memorandum of Understanding,23 to strengthen

collaboration between FSIS inspectors and OSHA enforcement staff

and ensure identification and reporting of safety hazards

impacting working conditions of FSIS inspectors and those of

establishment employees.

Comments: Comments from animal welfare advocacy

organizations and private citizens concerned about animal

welfare asserted that revoking maximum line speeds for

establishments that operate under NSIS will have adverse effects

on the humane handling of swine. The comments expressed concern

that faster line speeds would increase the potential for workers

to force animals to move faster than normal walking speeds and

for ineffective stunning. Most of these comments referenced an

undercover video that was taken at a HIMP establishment in 2015.

According to the commenters, the video showed hogs that were

beaten and electrically prodded to move to keep up with the

slaughter line speed. The commenters claimed that the video

showed hogs that were conscious when they entered the scalding

tank because they were improperly stunned.

23 The MOU is available at: https://www.osha.gov/laws-regs/mou/1994-02-04.


82

Several animal welfare groups also claimed that

establishment employees are pressured by establishment

management to never slow the slaughter line. A few commenters

stated that they found a Memorandum of Interview (MOI) issued in

2017 to a HIMP establishment that stated that an FSIS inspector

observed that hog handlers were driving animals too fast and

with more excitement than necessary, in violation of 9 CFR

313.2. According to the commenters, the MOI also stated that the

inspector’s concerns had been raised at least twice at weekly

meetings with establishment management. The commenters argued

that the MOI shows that hogs are routinely forced to move too

fast in HIMP establishments.

One commenter supported FSIS’s decision to add a second

offline inspector to conduct additional offline activities such

as monitoring compliance with the HMSA. However, the commenter

opposed FSIS’s decision to decrease the total number of FSIS in-

plant personnel.

Response: FSIS disagrees that revoking line speeds will

have a negative effect on animal welfare. As the Agency

explained in the proposed rule, FSIS was able to conduct more

offline humane handling verification tasks under HIMP as

compared to traditional inspection. As is the case under HIMP,

more inspection resources will be available to verify whether


83

establishments meet humane handling requirements as an offline

activity under NSIS.

Regarding the undercover video, multiple FSIS experts –

including trained veterinarians and humane handling experts –

reviewed the video and determined that there was unacceptable

rough handling and inappropriate use of a rattle paddle to drive

animals. FSIS took immediate regulatory action against the

establishment and required it to respond with acceptable

corrective actions to prevent a recurrence.

While a person in the video suggests that animals were

conscious after stunning, FSIS found that the animals appeared

properly stunned and insensible to pain, as required by Federal

law. The video was reviewed by a professor of animal science,

who reached the same conclusion.

FSIS reviewed the 2017 MOI that stated that an FSIS

inspector observed that hog handlers were driving animals too

fast and with more excitement than necessary. FSIS has

instructed its inspection personnel to properly document

noncompliance in NRs and not MOIs.

Comment: One animal welfare organization noted that they

submitted a petition in 2014 requesting that the Agency require

all swine slaughter establishments to immediately and humanely

euthanize non-ambulatory disabled (NAD) pigs. According to the

petition, prohibiting the slaughter of NAD pigs would improve


84

inspection efficiency and compliance with the HMSA, as well as

reduce Salmonella risks. The animal welfare organization argued

that FSIS must respond to their petition before finalizing the

proposed rule.

Response: After carefully considering the issues raised in

the petition, along with the referenced information and other

letters received in support of the petition, FSIS has concluded

that its existing regulations and inspection procedures are

sufficient and effective in ensuring that NAD pigs are handled

humanely at slaughter and in preventing diseased animals from

entering the human food supply. Consequently, the Agency is

denying the petition. The Agency’s final petition response is

available at

https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/pet

itions. FSIS denied a similar petition in 2013 requesting that

the Agency prohibit the slaughter of all NAD livestock. That

petition response is also available at

https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/pet

itions.

F. Ready-to-Cook


associations representing members of the pork industry generally

support the proposed RTC pork product standard. However, the

commenters requested that FSIS amend the definition to include


85

language such as “reasonably free,” or “sufficiently free,” to

clarify that the RTC standard is a standard for non-food safety

defects and not a zero-tolerance standard.

These same commenters recommended that the Agency allow

establishments to apply the RTC standard at any appropriate

location at or before the point of packaging or to clarify that

the Agency intends this type of flexibility if that is the case.

One trade association said that because an establishment may

apply processes targeting RTC criteria and other quality issues

at various locations after the cooler, FSIS should not inspect

for RTC criteria before the cooler. The commenter argued that

there is no food safety concern associated with carcasses and

parts that may not yet meet the RTC standard entering the

cooler.

Members of the pork industry, trade associations, and a

foreign country asked FSIS to clarify when FSIS inspectors can

slow or stop the evisceration line because of non-food safety

defects in establishments operating under NSIS. These commenters

also asked FSIS to clarify how the Agency will document

noncompliance with RTC standards. According to the commenters,

online inspectors should be instructed to stop the line only to

remove food safety defects after the establishment’s final

control, and NRs should only be given after offline personnel

assess and confirm a loss of process control.


86

A trade association noted that several processing defects

covered in the RTC definition are listed under 9 CFR 310.18(a),

which applies to all swine establishments and is typically

enforced as a zero-tolerance standard. The commenter also noted

that 310.18(a) is regularly categorized as a PHR. The commenter

was concerned that if an NSIS establishment receives an NR for 9

CFR 310.18(a) for failure to meet RTC standards, it will

unjustly influence the establishment’s PHR rate. Rather than

cite 9 CFR 310.18(a), the commenter suggested that inspectors

should cite 9 CFR 310.26(d)(1) for products not meeting RTC

standards at NSIS establishments to delineate NRs for non-food

safety issues from NRs for food safety issues.

Response: Under NSIS, establishments will have the

flexibility to design and implement measures to address OCP

defects that are best suited to their operations. They will also

be responsible for determining the type of records that will

best document that they are meeting the RTC pork product

definition. The records will be subject to review and evaluation

by FSIS offline inspectors (9 CFR 310.26(d)(1)).

FSIS has decided to amend the definition of RTC pork

product to clarify that it is not a zero-tolerance standard. RTC

pork product will now be defined as “any slaughtered pork

product sufficiently free from bile, hair, scurf, dirt, hooves,

toe nails, claws, bruises, edema, scabs, skin lesions, icterus,


87

foreign material, and odor, which is suitable for cooking

without need of further processing.”

FSIS also is clarifying that the RTC definition applies to

pork products at the end of the slaughter process and before

carcasses and parts enter the cooler. This is consistent with

the Agency’s requirements under HIMP and NPIS.

FSIS will issue instructions to its inspectors on how to

verify the RTC pork product requirements using the routine and

directed PHIS Swine RTC task. When conducting the routine task,

FSIS offline inspectors will verify that an establishment

maintains records as required by 9 CFR 310.26(d)(1). FSIS will

issue an NR for 9 CFR 310.26(d)(1) if an establishment does not

have records to document that the products resulting from its

slaughter operation meet the definition of RTC pork product.

If FSIS online inspectors believe that the presentation of

persistent unattended trim or processing defects indicates a

lack of process control, they will notify the PHV. The PHV may

then tell an offline inspector to conduct a directed PHIS Swine

RTC task. FSIS offline inspectors will follow the same method

and apply the same criteria that the establishment uses to check

that they are meeting the RTC standard. FSIS will issue an NR

for 9 CFR 310.26(d)(1) if the results exceed the criteria set by

the establishment or if the establishment did not take the


88

necessary corrective actions to restore process control when the

evaluation criteria was exceeded.

If the PHV determines that the presentation of persistent

unattended trim or processing defects indicates a loss of

process control that affects the online inspectors’ ability to

adequately conduct a carcass-by-carcass inspection, the PHV will

direct the establishment to reduce its line speeds. The PHV will

then issue an NR citing 9 CFR 310.26(d)(1).

FSIS inspectors will use PHIS to link all NRs that are

issued for the failure to meet the RTC pork product standard and

associated documentation requirements. If establishment

management is unwilling or unable to take the necessary steps to

re-establish control of its process to meet RTC regulatory

requirements, FSIS inspectors will discuss the issue with their

supervisor and the DO. The DO will notify the establishment in

writing that repeated NRs may lead the Agency to take a

regulatory control action (9 CFR 500.2).

In the rare case that FSIS online inspectors identify a

carcass so affected with non-food safety defects (e.g.,

malignant lymphoma, icterus, or uremia) that the entire carcass

must be condemned, they will stop the line for carcass

condemnation unless the establishment provides a rail-out loop

to rail carcasses offline for reexamination and condemnation.

G. Implementation


89

Comment: One member of the pork industry supported the NSIS

implementation strategy suggested in the proposed rule. However,

the pork producer requested more information on whether two

shift operations must convert both shifts to NSIS at the same

time. The same commenter also requested more information on what

would happen if an establishment that converted to NSIS decided

it wants to move back to traditional inspection.

A trade association noted that FSIS’s implementation plan

for NPIS was phased in with close coordination with DOs and

establishments. The commenter stated that FSIS should follow a

similar implementation plan for NSIS, with an initial

notification period for establishments that want to adopt NSIS

and an algorithm to determine transition order. This commenter

also suggested a phased-in approach for the mandatory provisions

for all swine establishments based on establishment size.

The same trade association stated that establishments

should submit for approval unique transition plans to the DO

when providing notification that they intend to adopt NSIS. The

trade association suggested that FSIS identify and provide

acceptable examples of transition plan elements. According to

the commenter, pre-approved elements should include

transitioning single inspection stations in succession, one

shift at a time, one inspection focus area (i.e., head


90

inspection) at a time, RTC monitoring before transitioning

inspection activities, and others.

Consumer advocacy organizations stated that only

establishments that have their HACCP plans approved by FSIS

should be allowed to implement NSIS. The commenters suggested

that FSIS should review every establishment’s HACCP plans to

determine if their tailored microbiological testing programs are

valid before allowing them to convert to NSIS.

Response: All market hog establishments will initially have

six months to notify their DO of their intent to operate under

NSIS. Establishments that do not notify their DO of their intent

to transition during this time will be deemed to have chosen to

continue to operate under traditional inspection. Market hog

establishments that decide that they would like to convert to

NSIS after the initial six-month notification period end date

may notify their DO of their intent to transition to NSIS at any

time after that date. The Agency will implement NSIS in the

additional establishments that intend to convert on a schedule

consistent with the availability of Agency resources and

establishment readiness.

Because there are fewer market hog establishments than

poultry establishments, the Agency does not think it will be

necessary to use an algorithm to determine transition order.

FSIS also does not think it is necessary to require


91

establishments to develop formal transition plans.

Establishments will need to transition all shifts and inspection

stations to NSIS at one time. However, FSIS DOs will work with

establishments to ensure a smooth transition from traditional

inspection to NSIS. And, if necessary, FSIS DOs will work with

establishments to ensure a smooth transition from NSIS back to

traditional inspection.

FSIS does not think it is necessary to review HACCP plans

before establishments convert to NSIS. FSIS already has

inspection tasks in place to verify that establishments are

properly implementing their HACCP systems in accordance with 9

CFR part 417.

The Agency is establishing separate applicability dates for

large, small, and very small establishments to comply with the

regulations that prescribe procedures for controlling

contamination throughout the slaughter and dressing process in 9

CFR 310.18(c), and the regulations that prescribe recordkeeping

requirements in 9 CFR 310.18(d). The applicability dates will

provide additional time for small and very small establishments

to comply with these provisions.

H. Environmental Assessment

Comments: Comments from an animal welfare advocacy

organization and an environmental advocacy organization stated

that before FSIS can finalize the proposed rule, the Agency must


92

prepare an Environmental Impact Statement (EIS), as required

under the National Environmental Policy Act (NEPA; 42 U.S.C.

4321 et seq.) because, according to these commenters, allowing

market hog slaughter establishments to increase line speeds will

result in significant environmental impacts. The commenters

stated that faster line speeds would mean more hogs slaughtered

per shift. According to the commenters, more hogs slaughtered

would mean more waste and more water use. The commenters

asserted that these are all significant environmental impacts,

with both individual and cumulative effects at the local, state,

and national levels. The commenters also stated that FSIS cannot

claim the categorical exclusion from the preparation of an

Environmental Assessment (EA) or an EIS under 7 CFR part 1b of

the USDA regulations.

Response: FSIS maintains that this rulemaking is

categorically excluded from NEPA requirements. Federal agencies

may identify classes of actions that normally do not require the

preparation of either an EA or EIS because such actions do not

have a significant effect on the human environment, either

individually or cumulatively (40 CFR 1507.3(b)(2)). Such classes

of actions are “categorically excluded” from NEPA requirements

(40 CFR 1508.4). Under 7 CFR 1b.4, all FSIS actions, including

inspection functions, are categorically excluded from

preparation of an EA or EIS unless the Agency head determines


93

that a particular action may have a significant environmental

effect. Accordingly, FSIS is not required to prepare an EA or

EIS unless it anticipates that this rule may have a significant

environmental effect.

The Agency does not anticipate that its decision to revoke

maximum line speeds for establishments that operate under NSIS

will have individual or cumulative effects on the environment.

As FSIS explained in the proposed rule, expected sales of pork

products to consumers will determine the total number of hogs

that an establishment slaughters, not the maximum line speed

under which it operates. The Agency has no authority to

determine an establishment’s production levels. An establishment

may decide to increase production hours to slaughter more hogs

in response to market demand, regardless of its maximum line

speed. Revoking maximum line speeds allow establishments to

slaughter hogs more efficiently but will not directly affect

consumer demand for the establishment’s pork products. In some

instances, an establishment operating under NSIS may be able to

reduce its hours of operation while maintaining production at a

rate necessary to meet market demand for its meat products.

Thus, revoking line speeds is not expected to determine the

number of hogs slaughtered or result in more waste or more water

use, as suggested by the commenters.


94

In addition, all slaughter establishments, regardless of

line speed, are required to meet all local, State, and Federal

environmental requirements.

Sampling

Comments: Comments from consumer advocacy organizations and

public health organizations supported FSIS’s decision to require

establishments to develop written procedures to prevent and

mitigate microbial contamination of carcasses throughout the

entire slaughter and dressing operations and incorporate the

intervention strategies into their HACCP systems. These same

commenters stated that sampling at pre-evisceration and post-

chill will make it easier for establishments to see if their

process control system is working. According to the commenters,

microbial testing at the end of the process encourages industry

to focus primarily on post-slaughter interventions, while the

new approach encourages them to focus on prevention and

mitigation of microbial contamination throughout the slaughter

process.

Response: FSIS agrees that requiring establishments to keep

written records to document the implementation and monitoring of

their process control procedures is a positive step forward for

public health. This ongoing documentation will allow both the

establishment and FSIS to identify specific points in the

production process where a lack of process control may have


95

resulted in product contamination or insanitary conditions. This

will allow the establishment to take the necessary corrective

actions to prevent further product contamination.

Comments: Comments from members of industry stated that

FSIS should revise the proposed rule to remove sampling schemes

based on establishment size. According to the commenters, basing

sampling frequency on the size of the establishment is not

supportable from a statistical sampling point of view. The

commenters suggested that FSIS propose a minimum sampling

frequency for all establishments based on the number of head

slaughtered, over a certain time period.

Response: FSIS changed its proposed sampling frequency to

remove the exception for very small establishments. Under this

final rule, very small establishments will need to sample

carcasses at pre-evisceration and post-chill (for hot-boned

product, carcasses sampled at pre-evisceration and after the

final wash) at a frequency of one per 1,000 carcasses. However,

FSIS has decided to keep the exception for very low-volume

establishments. This change makes the sampling requirements for

swine slaughter establishments more consistent with the sampling

requirements for poultry slaughter establishments. Additionally,

if FSIS adopted a sample frequency of one per 1,000 carcasses

for very low-volume establishments, many of these establishments

would not have to sample at all.


96

Comment: Several consumer advocacy organizations and one

public health organization objected to FSIS’s proposal to allow

establishments to develop their own sampling and testing

protocols and to use alternate sampling locations and

frequencies. These same commenters argued that it would be too

difficult for FSIS inspectors to verify sampling plans that use

alternate sampling locations and frequencies. Two consumer

advocacy organizations argued that FSIS’s Salmonella performance

standards remain a core element of HACCP and should not be

eliminated under the proposed rule. One consumer advocacy

organization argued that FSIS must not move forward with

proposed inspection changes without maintaining a pathogen-

specific performance standard. The commenter argued that

modernized, HACCP-based inspection cannot function adequately

without such a performance standard. The commenter further

stated that uniform microbial testing is necessary to evaluate

the impact of FSIS’s planned inspection changes, as the Agency

will not be able to verify trends in pathogen rates caused by

the inspection changes without an effective national testing

program.

One consumer advocacy organization argued that FSIS should

maintain the current generic E. coli testing standard. Although

the commenter did not oppose substitution of another indicator

organism for generic E. coli, they argued that FSIS must ensure


97

that any newly permitted testing program is evidence-based and

equal or superior to the prior generic E. coli standard for

fecal contamination detection. The commenter recommended that

FSIS require establishments who seek to use an alternative

testing program to the generic E. coli standard to apply for a

regulatory waiver, which would allow for pre-implementation

Agency review.

Response: The purpose of the new sampling requirement is to

ensure that establishments monitor and evaluate the

effectiveness of their procedures to prevent contamination of

carcasses by enteric pathogens, and visible fecal material,

ingesta, and milk on an ongoing basis. It is not intended to

generate data to compare establishment performance across the

industry.

However, FSIS has determined that it may be too difficult

for inspectors to review and verify sampling plans that use

alternate sampling frequencies and locations. As a result, FSIS

is withdrawing the proposal to allow establishments to use

alternate sampling frequencies and locations. Establishments

that still wish to use alternate sampling frequencies and

locations may submit a SIP waiver request to FSIS for review.24

24 See FSIS Compliance Guideline Procedures for New Technology Notifications and Protocols available at https://www.fsis.usda.gov/wps/wcm/connect/c64d8f3b-56aa-49c9-91f3-daf0caaba6bd/New-Technology-Protocols-042015.pdf?MOD=AJPERES.


98

As is noted above, FSIS will provide information about waiver

criteria in a future Federal Register document.

As FSIS explained in the proposed rule, FSIS discontinued

its Salmonella verification sampling program for market hogs

(carcasses) in 2011 to make better use of its resources. Because

verifying the codified performance standards for market hogs was

not a good use of Agency resources, and the standards have not

been used since 2011, FSIS is removing the carcass Salmonella

performance standards for market hogs. With that said, FSIS is

currently testing pork cuts and comminuted pork products for

Salmonella and expects to decide in 2019 whether to develop new

pathogen performance standards for these products or take other

actions to address Salmonella in these products.25 FSIS pathogen

test results for pork products are posted quarterly on the FSIS

Web site:

https://www.fsis.usda.gov/wps/wcm/connect/df529ce7-575a-43e7-

9219-48be29c80fa5/Sampling-Project-Results-

Data.xlsx?MOD=AJPERES.

Establishments may continue to sample for generic E. coli.

FSIS considers the requirements under the former regulations for

generic E. coli to be a scientifically validated “safe harbor”

25 See U.S. Govt. Accountability Office, GAO-18-272, Food Safety: USDA Should Take Further Action to Reduce Pathogens in Meat and Poultry Products (March 2018). https://www.gao.gov/assets/700/690709.pdf.


99

for monitoring process control, specifically for fecal

contamination. FSIS previously granted waivers under the SIP to

the generic E. coli testing regulations for establishments that

want to test for other indicator organisms. Establishments

operating under these waivers have demonstrated that they are

able to effectively maintain process control based on their SIP

sampling data.

Comments: Several members of industry, trade associations,

and a State Department of Agriculture objected to the proposed

pre-operational environmental sampling requirements. One HIMP

establishment stated that environmental sampling would be an

expensive change with little value. The commenter argued that

current HIMP establishments have not been required to conduct

environmental sampling beyond those tests that may also meet the

Sanitation SOP requirements, and these establishments have shown

consistent or better performance controlling for Salmonella.

A few public health organizations stated that requiring

facilities to monitor and assess food contact surfaces for

enteric pathogens is a reasonable measure given that recent

investigations of Salmonella foodborne illness outbreaks

revealed food contact surfaces to be contaminated with the

outbreak strain. The commenters stated that requiring pre-

operational environmental sampling should help ensure that

surfaces are sanitary and free of enteric pathogens.


100

Response: This final rule does not require swine slaughter

establishments to develop, implement, and maintain in their

HACCP systems written procedures to prevent contamination of the

pre-operational environment by enteric pathogens. In response to

concerns about the regulatory burden, FSIS has decided to

withdraw this part of the proposal until it considers options

and timing for gathering more data on enteric pathogen

contamination in the pre-operational environment. FSIS agrees

that current HIMP establishments have shown consistent

performance controlling for Salmonella.

Comments: Several members of industry, industry trade

associations, and private individuals objected to certain

content in the sampling guide. These commenters argued that the

language in the sampling guide is prescriptive in both tone and

language and implies mandatory requirements. The commenters

stated that the sampling guide includes unhelpful and

problematic sampling methods, techniques, and analysis, as these

depend on individual establishments’ sampling programs. For

example, several commenters argued that, absent codified

standards, Table 4 in the sampling guide would be a de facto

performance standard, contrary to the objectives in the proposed

rule. The commenters stated that the sampling guide should be

revised to promote sampling programs tailored to each

establishment. One industry commenter further argued that the


101

word "compliance" should be removed from the document title to

be consistent with recent changes to other FSIS guidance

documents and because the document provides best practice

recommendations and not regulatory requirements.

Response: FSIS guidance documents are intended to provide

best practices and, in some cases, safe harbors based on the

most current science available to Agency stakeholders to help

them comply with regulatory requirements, and when applicable,

meet performance standards. The sampling guide explains that

FSIS considers the requirements under the former regulations for

generic E. coli to be a scientifically validated “safe harbor”

for monitoring process control for very low-volume

establishments. The sampling guide also includes recommendations

to assist small and very small establishments to meet regulatory

requirements, and recommendations to develop a custom approach

that are not dependent on establishments’ available resources.

For example, the sampling guide provides baseline information

for those establishments that may need a starting place from

which to calculate their own control limits. However, control

limits change over time as establishment-specific data is

collected and analyzed. FSIS has removed Table 4 and replaced it

with a new table (Table 2) to provide better guidance for

establishments that may want to use data from the 2010-2011

market hog baseline survey as an initial starting point from


102

which to set their upper control limits. Therefore, the

information provided in the document is not a performance

standard.

In response to the comments, FSIS has revised the sampling

guide to, in part, further clarify the purpose of the document,

which is to assist small and very small establishments to comply

with the new microbial organism sampling requirements that apply

to all swine slaughter establishments under this final rule. The

sampling guide has also been revised to include additional

information on the intended use of provided methods, techniques,

and analyses; and to remove the word “compliance” from the

document title and clarify that the document does not constitute

regulatory requirements. Additionally, the Agency moved the

example control charts from the sampling guide from the sampling

guide to Appendix 2 of the guideline and clarified how

establishments can use control charts. The Agency did not

recommend a specific control chart format. Finally, the Agency

removed all references to pre-operational environmental

sampling. The updated sampling guide is available at


compliance/compliance-guides-index.

Comments: Several commenters objected to certain

information provided in the sampling guide related to indicator

organism sampling and testing. One industry commenter stated


103

that both the proposed rule and the sampling guide, as written,

could mandate a shift from analyzing market hog carcasses for

enteric pathogens of concern, such as Salmonella, to monitoring

a surrogate, such as Aerobic Plate Count (APC). The commenter

argued that this process control approach is too singular, and

FSIS should clarify in the sampling guide that establishments

will maintain the flexibility to select for one or more

indicator organisms. In addition, several commenters argued that

FSIS should revise the sampling guide to remove sampling schemes

based on establishment size. They stated that, from a

statistical sampling viewpoint, establishing sampling frequency

based on the size of the establishment is not supportable. These

commenters also stated that generic E. coli testing should not

remain a "safe harbor," even for small and very small

establishments, because no scientific correlation exists between

microorganism presence/growth and facility size. Finally, one

industry commenter noted that the sampling guide does not

summarize all known control points for Salmonella, as the

document claims it does.

Response: The sampling guide provides flexibility and

monitoring options for establishments, and it makes clear that

establishments may select one or more indicator organisms to

monitor.


104

To address the comment about the singular process control

approach, the sampling guide provides a link to the December

2013 FSIS guideline for controlling Salmonella in market hogs,

which describes potential control points for Salmonella in the

pre- and post- harvest production process. The potential control

points described in that 2013 guideline may or may not be

applicable to a specific establishment's process.

Comments: Several commenters expressed concerns with

information provided in reference and example charts throughout

the sampling guide. One member of the pork industry and one

trade association representing the pork industry argued that

establishments should not compare process control results to a

nationwide geometric mean displayed in one chart. The commenters

argued that market hog data is an inappropriate basis for

developing upper control limits, as it is not applicable to all

swine establishments. Further, they stated that these data from

2011 are outdated. One commenter stated that “under NSIS” should

be removed from one table column heading, as the information

would apply to all swine establishments.

Response: FSIS revised the sampling guide to remove the

table that provided averages that represented the 80th percentile

limits for each indicator organism included in FSIS’s 2010-2011

market hog baseline survey. The Agency also removed the “under


105

NSIS” language from the table that provides information for all

swine establishments

In cases where an establishment does not have the resources

or capacity to initially develop its own statistical control

limits or analytical procedures, an establishment can utilize

the aggregated data from the FSIS Nationwide Market Hog

Microbiological Baseline Survey. The 2010-2011 baseline survey

provides a wealth of microbiological data specific to swine

carcass sampling; these data are meant to provide a starting

point for an establishment to develop its own control limit

parameters over time. During the survey, FSIS collected two

carcass samples at pre-evisceration and post chill.

Comment: One member of the pork industry and one trade

association representing the pork industry recommended that FSIS

remove from the sampling guide information related to finished

product standard (FPS) waivers, as the subject is unrelated to

the sampling guide.

Response: FSIS has removed the FPS waiver information from

the sampling guideline.

I. Economic Assessment

Comment: One company that owns a HIMP establishment said that

the cost of additional employees has been their most significant

cost from the HIMP pilot study, and that they have had to hire


106

and train up to 11 employees per shift to staff and maintain the

inspection process.

Response: FSIS incorporated information from this comment into

section III.G.1.a by revising the upper bound estimate from 10

employees to 11 in the description of additional establishment

workers likely to be required by establishments that adopt the

NSIS.

Comment: One industry commenter estimated that a full-time

position, per slaughter shift, would be required to collect,

record, and analyze data required to verify that an

establishment’s products meet the definition of RTC.

Response: While establishments are free to design their own

process control monitoring systems, FSIS finds the estimated

time and labor requirement provided in this comment to be

inconsistent with FSIS’s observations of HIMP establishments

verifying OCP performance standards. FSIS explained in the

proposed rule that pork carcasses that meet the HIMP OCP

performance standards would meet the RTC pork product

definition. Large swine establishments can verify OCP

performance standards by taking 24 carcass samples per shift,

requiring roughly one hour to collect, record, and analyze the

data.

Comments: Several comments from members of the pork

industry stated that they own establishments that operate under


107

SIP waivers and conduct process control sampling at alternate

frequencies.

Response: FSIS incorporated the information from these

comments into section III.G.2.b of the final rule and used it to

revise the cost estimate associated with changes to requirements

for microbial organism process control sampling and analysis.

This revision caused a slight decrease in potential industry

savings. Under the SIP, 11 large swine establishments currently

sample at an alternative frequency and the Agency assumes that

these establishments will continue to do so when the

applicability dates for this final rule arrive. As such, these

establishments are not expected to change their process control

sampling and will not experience a change in associated costs.

Comment: One member of the pork industry claimed that

process control sampling requirements would increase cost.

Response: As is detailed in section III.G.2.b of the final

rule, overall, the changes in process control sampling

requirements were estimated to reduce industry wide sampling

costs by about $0.57 million annualized over 10 years, applying

a three percent discount rate.

Comment: One member of the pork industry reported that all

six of their company’s facilities have written sanitary dressing

plans.


108

Response: FSIS incorporated information from this comment

into section III.G.2.a of the final rule to reduce the cost

estimate associated with developing, composing, training,

monitoring, recording, and verifying written sanitary dressing

plans to reflect that six establishments already have written

sanitary dressing plans.

Comment: One company stated that many small and very small

establishments are unlikely to adopt the NSIS due to the

program’s costs.

Response: FSIS agrees that many small and very small

establishments are unlikely to adopt the NSIS. The Agency’s cost

benefit analysis assumes that very small establishments that

exclusively slaughter market hogs do not have a high enough

production volume to justify incurring the costs of converting

to the NSIS.

Comment: One company participating in HIMP stated that it

invested in capital expenditure projects to add or relocate

inspection stations and reconfigure lines.

Response: The NSIS may require a minor capital improvement

if the establishment does not already provide a mirror at the

carcass inspection station. All the large high-volume

establishments are already required to provide mirrors under

existing regulations. Providing a mirror is a minor potential


109

cost for a limited number of establishments.26 If an

establishment believes that additional capital expenditures will

result in a benefit, they may voluntarily reconfigure or update

their facilities to fully capture all the potential production

efficiencies offered through participation in NSIS. Examples of

such changes include line reconfiguration, which can cost

between $10,000 and $250,000 and the creation of an inspection

station, which can cost between $5,000 and $6,000.

Establishments may reduce these costs by coordinating these

facility updates with previously planned establishment

renovations.

Comment: A few consumer advocacy organizations claimed that

the Agency’s cost benefit analysis understated training costs

because the industry has a high turnover rate, necessitating

that training take place more frequently than once per year.

Response: FSIS used BLS’ industry turnover rate for non-

durable manufactured goods to estimate annual training costs.

Section III.G.1.a of the final rule provides additional details

on how the cost benefit analysis estimates industry’s training

costs, which includes training new employees given the

industry’s turnover rate.

26 The cost was estimated to be very small because all 22 large high-volume establishments and potentially several of the 13 small high-volume establishments are already required to provide mirrors. As such, any new expense would be negligible compared to the industry costs included in the cost-benefit analysis.


110

Comments: Several commenters stated that the Agency’s

guidance documents will likely need to be translated into

additional languages. One commenter claimed that industry would

be forced to hire translators to translate the Agency’s guidance

documents, the cost of which was not included in the cost

benefit analysis.

Response: The Agency plans to make translated guidance

documents publicly available as the need arises at no cost to

industry. The cost of translating these documents is already

within the Agency’s budget. As such, the cost is not expected to

increase the Agency’s budgetary needs and is therefore not

included in the rule’s cost analysis.

III. Executive Orders (E.O.s) 12866 and 13563

E.O.s 12866 and 13563 direct agencies to assess all costs

and benefits of available regulatory alternatives and, if

regulation is necessary, to select regulatory approaches that

maximize net benefits (including potential economic,

environmental, public health and safety effects, distributive

impacts, and equity). E.O. 13563 emphasizes the importance of

quantifying both costs and benefits, of reducing costs, of

harmonizing rules, and of promoting flexibility. This final rule

has been designated a “significant” regulatory action under

section 3(f) of E.O. 12866. Accordingly, the rule has been

reviewed by the OMB under E.O. 12866.


111

A. Updates to the Regulatory Impact Analysis (RIA)

FSIS updated the proposed rule’s RIA to reflect the changes

made in the final rule in response to public comments. The

changes to the costs and benefits sections incorporate the

following factors:

• The Agency removed the mandatory pre-operational

environmental sampling requirement.

• Establishments currently operating under SIP waivers

conduct process control sampling at an alternative

frequency and the Agency assumes that they will

continue to do so when the applicability dates for

this final rule arrive. Therefore, these

establishments have been removed from the cost

estimate associated with changes to requirements for

microbial organism process control sampling and

analysis.

• Additional information from the risk assessment that

more transparently demonstrates the potential

uncertainty, is now reflected in the cost-benefit

analysis. However, the anticipated net benefit did

not change.

• One company reported that all 6 of its

establishments already have written sanitary


112

dressing plans. As such, the annual cost estimate

associated with developing, composing, training,

monitoring, recording, and verifying written

sanitary dressing plans has been revised down by

approximately $87,000.

• The highest number of establishment employees to be hired

to meet the needs of NSIS has been revised up to 11,

based on an industry comment.

• The per head margin has been updated to rely on the

North American Meat Institute’s (NAMI’s) 2017 Meat

and Poultry Facts.27

B. Need for the Rule

The swine slaughter industry in the United States has

evolved since Congress enacted the Wholesome Meat Act in 1967.

Many of today’s producers have invested in farm to table quality

and food safety controls that effectively address health risks

and consumer quality issues.28 For these producers, the

prescriptive nature of some FSIS regulations inhibits efficient

production and the adoption of improved production methods and

restricts their ability to adopt new technologies. Further, at

large and high-volume establishments that exclusively slaughter

27 Nalivka, J. S., The 2017 Meat and Poultry Facts, NAMI August 2018. 28 Key, Nigel and William McBride. 2007. The Changing Economics of U.S. Hog Production. USDA Economic Research Service (ERS.). Report No. 52


113

market hogs, the current regulations that require FSIS to focus

on non-food safety issues prevent FSIS from efficiently

allocating resources, which inhibits food safety improvements

and humane handling hazard prevention. Therefore, while

traditional inspection is generally sufficient for low-volume

establishments and for establishments that slaughter classes of

swine other than market hogs, a modernized swine slaughter

inspection system is needed, one that is less prescriptive,

creates incentives for establishments to develop and invest in

advancements in food safety and quality controls and procedures,

and allows FSIS to improve inspection methods.

Baseline

C. Overview of the Market

U.S. pork production has increased at a moderate pace as

seen in Table 2. Much of the additional growth in domestic

production has been used to satisfy increasing export demands,

which increased 43 percent between 2009 and 2018.29 According to

the Food and Agricultural Organization (FAO), pork is

29 Livestock and Meat Domestic Data, All supply and disappearance, Historical, WASDE Pork-Full. USDA ERS Livestock and Meat Domestic Data. <https://www.ers.usda.gov/data-products/livestock-meat-domestic-data/livestock-meat-domestic-data/#All%20meat%20statistics> accessed on 6/12/2019. Last updated on 5/29/19


114

consistently ranked as the top meat in per-capita consumption

worldwide30 and is ranked third in the United States.31

Table 2: U.S. Pork Supply and Demand (Carcass Weight, Million Pounds)

Year U.S.

Production Imports Exports

Consumption

Domestic Per Capita*

2009 22,999 834 4,094 19,869 65

2010 22,437 859 4,223 19,077 62

2011 22,758 803 5,196 18,382 59

2012 23,253 802 5,379 18,607 59

2013 23,187 880 4,986 19,104 60

2014 22,843 1,011 5,092 18,836 59

2015 24,501 1,116 5,010 20,592 64

2016 24,941 1,091 5,239 20,892 65

2017 25,584 1,116 5,632 21,034 65

2018 26,315 1,042 5,870 21,497 66 * Measured in carcass weight, pounds Source: Livestock and Meat Domestic Data, All supply and disappearance, Historical, WASDE Pork-Full. USDA ERS Livestock and Meat Domestic Data. <https://www.ers.usda.gov/data-products/livestock-meat-domestic-data/livestock-meat-domestic-data/#All%20meat%20statistics> accessed on 6/12/2019. Last updated on 5/29/19

In 2016, there were approximately 612 swine slaughter

establishments under Federal inspection, Table 3.32 Combined,

30 FAO Livestock commodities. < http://www.fao.org/docrep/005/y4252e/y4252e05b.htm> Accessed on 11/29/16. 31 Livestock and Meat Domestic Data, All supply and disappearance, Historical. USDA ERS Livestock and Meat Domestic Data. <https://www.ers.usda.gov/data-products/livestock-meat-domestic-data/livestock-meat-domestic-data/#All%20meat%20statistics> accessed on 6/12/2019. Last updated on 5/29/19 32 USDA, FSIS, Public Health Information System (PHIS).

http://www.fao.org/docrep/005/y4252e/y4252e05b.htm


115

these establishments process roughly 118 million hogs annually.

FSIS divides swine into the following production categories for

data collection purposes: roaster swine, market hog, sow, and

boar/stag. Today, the majority (97%) of the pork products

available in the market are derived from market hogs.33

Table 3: Number of Swine Slaughter Establishments by Size, 2016

HACCP Processing

Size No. of

Establishments

Total Swine Slaughter

(Head Count)

Total Market Hog

Slaughter (Head Count)

Percent Market Hog

Large 28 105,678,519 105,321,950 99.66% Small 105 11,862,341 8,497,891 71.64% Very Small* 479 903,009 625,863 69.31% Total 612 118,443,869 114,445,704 96.62%

Source: Public Health Information System (PHIS) * Two establishments classified as N/A were included in the category total for Very Small establishments.

As shown below in Table 4, many establishments now

exclusively slaughter market hogs, a species sub class which,

because of technological and animal management improvements,

such as improved genetics, nutrition, and medical services,

generally presents fewer food safety and quality issues.34

D. Overview of the Final Rule’s NSIS

Several of the final rule’s provisions apply to only those

establishments that choose to participate in the optional NSIS.

33 Source: PHIS 34 Key, Nigel and William McBride. 2007. The Changing Economics of U.S. Hog Production. USDA ERS. Report No. 52


116

Meeting these provisions will likely increase an establishment’s

labor and training costs. Only market hog slaughter

establishments are eligible to participate in the NSIS. Due to

the economic constraints, FSIS expects that only large and small

high-volume establishments that exclusively slaughter market

hogs will choose to participate in the optional NSIS. In 201635,

there were 40 high-volume establishments that exclusively

slaughtered market hogs: 2736 large37 (5 HIMP + 22 non-HIMP)38 and

13 small establishments, Table 4. These establishments account

for 93 percent of total swine slaughter annually, Table 4. Given

their large share of the market and the ability to slaughter a

sufficient number of market hogs to justify the likely costs

associated with the NSIS, these 40 market hog establishments are

expected to choose to implement the optional NSIS. Therefore,

this analysis calculates the costs and benefits associated with

the NSIS provisions for these 40 market hog establishments.

However, because the 5 HIMP establishments already meet NSIS

requirements, they are not expected to incur any additional new

35 Establishment level data from 2016 was used in both the Preliminary Regulatory Impact Analysis (RIA) and the Final RIA. 36 In 2016 there was 1 large establishment that did not exclusively slaughter market hogs. As such, this analysis assumed they would not choose to participate in the optional NSIS and were excluded from the relevant sections in the analysis. 37 HACCP size: Very Small Establishment = Less than 10 employees or less than $2.5 million in annual sales; Small Establishment = 10-499 employees; Large Establishment = 500 or more employees. 38 In 2016, there was 1 large establishment that did not exclusively slaughter market hogs.


117

costs nor contribute to any increase in quantified benefits

associated with adopting the NSIS.

Table 4. Head Count Distribution Across Types of Establishments, 2016

Type of Establishment

HACCP Size

No. of Establishments

Total Swine Slaughter

(Head Count)

Percent of

Total Head Count

High-Volume Market Hog Only

Large – HIMP 5 17,517,254 14.79%

Large - Non-HIMP 22 87,746,770 74.08%

Small 13 4,617,680 3.90%

Low-Volume Market Hog Only Very

Small 71 32,360 0.03%

Mix of Species and Swine Sub

Classes

Large/ Small 93 7,659,156 6.47%

Very Small 408 870,649 0.74%

Grand Totals 612 118,443,869

* HACCP sizes were combined so as to not reveal proprietary information. Source: PHIS

E. Overview of the Final Rule’s Mandatory Components

All swine slaughter establishments will need to comply with

the two mandatory provisions of the final rule discussed below.

1. Written Sanitary Dressing Plans


118

FSIS is amending 9 CFR 310.18 to require swine slaughter

establishments to develop, implement, and maintain as part of

their HACCP systems, written procedures to ensure that no

visible fecal material, ingesta, or milk is present by the point

of FSIS post-mortem inspection of swine carcasses. This

requirement will address a weakness of the current traditional

inspection system, which is that verification checks performed

at the end of the slaughter and chilling process encourage

industry to focus its activities on post-process interventions

to reduce contamination rather than prevention throughout the

slaughter process. Prevention throughout the slaughter process

is preferred because it promotes containing contamination close

to its origin, which reduces cross contamination of multiple

carcasses. The existing regulations require that establishments

prevent swine carcasses contaminated with visible fecal material

from entering the cooler. While preventing swine carcasses

contaminated with visible fecal material from entering the

cooler is an important safeguard for reducing the prevalence of

pathogens on swine carcasses, this result generally cannot be

effectively accomplished unless establishments implement

appropriate measures to prevent contamination from occurring

throughout the slaughter and dressing operation and implement

process control procedures for preventive measures. Requiring

establishments to keep daily written records to document the


119

implementation and monitoring of their process control

procedures is a positive step forward for public health. This

ongoing documentation allows both the establishment and FSIS to

identify specific points in the production process where a lack

of process control may have resulted in product contamination or

insanitary conditions. In addition, it will allow the

establishment to implement corrective actions that could include

the addition of preventive control measures to prevent

recurrence of similar product contamination events or insanitary

conditions.

Based on public comment, the final rule assumes all but six

establishments will need to develop written sanitary dressing

plans.

2. Process Control Sampling and Analysis for Microbial Organisms

Under this final rule, instead of following a prescribed

microbiological testing program, each establishment will be

responsible for developing and implementing its own

microbiological sampling plan. Each establishment, except very

low-volume establishments, is required to include carcass

sampling at pre-evisceration and post-chill (i.e., the point in

the slaughter process after the carcass has chilled in the

cooler and after all slaughter interventions are completed) or

for hot-boned products, carcass sampling at pre-evisceration and

after the final wash.


120

The microbiological standards prior to the final rule

prescribed that all establishments monitor process control by

sampling for generic E. coli. High-volume establishments were

required to take one sample per 1,000 carcasses or request an

alternative frequency. Very low-volume establishments were

required to take 1 sample per week of operation up to 13 times a

year. Several commenters from industry reported that each of

their establishments operating under SIP conduct process control

sampling at an alternative frequency. In addition, an industry

survey found that many establishments elect to perform other

microbiological tests in addition to testing for generic E.

coli.39

F. Overview of the Impact of the Final Rule on the Agency

This analysis, in part, takes into consideration potential

impacts to the Agency’s budget. FSIS’s budget is expected to be

impacted by changes in staffing and training requirements for

those establishments that choose to operate under the NSIS.

Under traditional inspection, each slaughter line requires up to

11 full-time positions. Generally, these positions include both

a supervisory and non-supervisory Public Health Veterinarian,

(PHV) (OPM Veterinary Medical Science Series, 0701); a

supervisory and non-supervisory consumer safety inspector, (CSI)

39 Viator, C. et. al. 2015. Meat Industry Survey in Support of Public Health Risk-Based Inspection. P5-42. Question 3.1.


121

(OPM Consumer Safety Inspection Series, 1862); and up to 7 Food

Inspectors, (FI) (OPM Food Inspection Series, 1863). There are

currently 418 full-time equivalent units (FTE) assigned to

slaughter inspection at the 22 large non-HIMP (27 large – 5

HIMP) and 13 small swine slaughter establishments expected to

convert to the NSIS, Table 5. When these establishments convert

to the NSIS, Agency personnel will require NSIS training.

Additionally, the number of Agency personnel required to inspect

the slaughter process will likely be reduced. See Agency

Staffing section for details.

Table 5: Current FSIS Slaughter Line Positions at Non-HIMP Establishments that Slaughter Exclusively Market Hogs OPM Job Code No. of Positions 1862 (CSI) 120

1863 (FI) 245 0701 (PHV) 53

Total 418 Source: PHIS

G. Potential Costs of the Final Rule

1. Costs Associated with the NSIS Components of the Rule

This analysis estimates the costs associated with the final

rule’s NSIS components. The 35 establishments that the Agency

assumes will adopt the NSIS portion of the rule have similar

characteristics to the 5 HIMP establishments, such as volume and

sub species slaughtered. Given the successful participation of

the 5 HIMP establishments in the pilot program and industry’s


122

continued interest in increasing the number of establishments

participating in the HIMP pilot study, the potential benefits

from adopting NSIS are expected to outweigh the potential costs.

This analysis assumes that very small establishments that

exclusively slaughter market hogs do not have a high enough

production volume to justify incurring the costs of converting

to the NSIS. While the 5 HIMP establishments are expected to

adopt the NSIS, they have already implemented the changes

associated with the NSIS by their participation in the HIMP

pilot study and are not expected to incur any new or additional

expenses. As such, they are not included in the group of

establishments expected to incur an increase in costs associated

with NSIS. The following analysis also excludes further

consideration of the costs of submitting an attestation of work-

related conditions due to its small estimated cost.40 Costs

examined generally fall under three categories: labor, capital

expenses, and developing written procedures.

In the following sections, this analysis presents the costs

and benefits generated over a range of assumptions with respect

to how much of the industry chooses to adopt the NSIS within

five years. As was done with the NPIS, this analysis assumes a

40 It was estimated that submitting such an attestation would require a Quality Control Technician with a labor compensation rate of $68.52 per hour, 2 minutes per year. Combined, submitting an annual attestation would cost all 27 large and 13 small establishments likely to adopt the NSIS approximately $91.36 annually (2 minutes * $68.52 per hour * 40).


123

5-year adoption period with roughly consistent annual adoption

rates. These estimates are scaled for an illustrative

calculation and assume that 35 of the 40 establishments that are

likely to adopt the NSIS will incur additional costs associated

with adoption. Using this illustrative calculation was supported

by one public comment, which suggested that adoption timing and

rate are difficult to estimate without a final rule. As is

stated above, the 5 HIMP establishments are not expected to

incur any additional costs associated with adopting the NSIS and

are therefore excluded when calculating potential costs of the

NSIS components of this final rule.

Table 6: NSIS Adoption Rate

Year

Total Number of Establishments

Adopted Percent Adopted Large Small

1 4 2 17% 2 8 4 34% 3 12 7 54% 4 17 10 77% 5 22 13 100%

a. Costs of Additional Establishment Workers

This analysis expects establishments operating under the

NSIS to experience an increase in labor costs. Under the NSIS,

establishments will be required to dedicate labor to sort and

remove unfit animals before ante-mortem inspection; trim and

identify defects, such as dressing defects, contamination, and


124

pathology defects, on carcasses and parts before post-mortem

inspection; identify animals or carcasses that they have sorted

and removed for disposal before FSIS inspection with a unique

tag, tattoo, or similar device, and to develop, implement, and

maintain written procedures to ensure that animals and carcasses

that have been sorted and removed for disposal do not enter the

human food supply and are properly disposed of; maintain records

to document the total number of animals and carcasses sorted and

removed per day and the reasons for their removal; while

conducting sorting activities, notify Agency inspectors if they

suspect that an animal or carcass has a reportable or foreign

animal disease; and maintain records documenting that products

resulting from their slaughter operations meet the new

definition of RTC pork product. Based on observations41 of HIMP

establishments and a comment from industry,42 this increase in

work is expected to require an increase in labor demand ranging

from 6-11 additional workers per line per shift at large

establishments. This analysis assumes each large establishment

that converts to the NSIS will require 9 additional workers per

line per shift. Due to data limitations, this analysis assumes

41 Observations were obtained through a survey conducted, in February 2016, through the Salmonella Initiative Program and conversations with industry at a meeting, which took place in February 2016, with the North American Meat Institute. 42 One corporation reported in a comment to the proposed rule that they hired and trained up to 11 employees per shift.


125

small establishments that convert to the NSIS will require 1

additional worker per line per shift. Costs associated with this

labor fall into 3 categories: wages and benefits, training, and

continuing education.

Establishment Labor Wage Increases

Many of the 22 large and 13 small non-HIMP market hog

establishments that are assumed to adopt the NSIS operate

multiple lines and shifts. Taking these multiple lines and

shifts into consideration, the number of industry positions is

estimated to increase by 383 if all high-volume establishments

that have a history of exclusively slaughtering market hogs,

adopt NSIS. The majority of these, 369, are attributable to the

large establishments (41 (number of lines) x 9)43, Table 7. The

remaining 14 positions are attributable to the small

establishments (14 (number of lines) x 1)44, Table 7. According

to the BLS, the estimated hourly wage for a Slaughterer and Meat

Packer occupation (“production employee”) is $13.00.45 A benefits

and overhead factor of two was then used to estimate the total

labor costs. The total hourly labor costs to industry for a

production employee including benefits and overhead, is $26.00

43 Source: PHIS 44 Source: PHIS 45 BLS Occupational Employment Statistics, Occupational Employment and Wages, May 2016. 51-3023 Slaughterers and Meat Packers <https://www.bls.gov/news.release/archives/ocwage_03312017.pdf> Accessed on 12/04/18. Last modified 3/31/17.


126

per hour ($13.00 x 246). Based on data obtained through PHIS, the

average large establishment slaughters swine 269 days annually.

Assuming workers work 8-hour shifts, the total annual

remuneration cost to these 22 large establishments is

approximately $20.65 million, (369 x $26.00 x 269 x 8), Table 7.

The average small establishment slaughters 244 days annually.

Again, assuming workers work 8-hour shifts, the total annual

remuneration cost to these 13 small establishments is

approximately $0.71 million, (14 x $26.00 x 244 x 8), Table 7.

These cost estimates take into consideration the fact that some

establishments operate multiple lines and multiple shifts.

Costs for Training Online Sorters and Carcass-Inspection Helpers

Establishments are expected to incur costs associated with

initially training employees to fill online sorter and carcass-

inspection helper positions, annual replacement training, and

continuing education training. This analysis assumes the cost to

train online sorters and carcass-inspection helpers are similar

to the costs of training production employees in HACCP, which

range from $274 to $823 with a midpoint average of $549 per new

employee.47 To ensure a conservative estimate and account for

employee rotation patterns as well as leave, FSIS assumes that

46 To be consistent with analyses done by the Department of Health and Human Services, this analysis accounts for fringe benefits and overhead by multiplying wages by a factor of 2. 47 Viator, C. Et. Al. 2015. Costs of Food Safety Investments. Table 4-4. Training Costs for Management and Production Employees.


127

establishments will train 4 employees for each new position.

Under these assumptions, large establishments will need to train

approximately 1,476 (369 x 4) employees, while small

establishments will need to train approximately 56 (14 x 4)

employees. The cost of this training ranges from $419,768 to

$1,260,836, with a midpoint estimate of $0.84 million (1,532 x

$549), Table 7.

To account for estimated turnover of establishment

employees, FSIS projects that establishments will have to train

approximately 452 (1,532 x 0.295) replacement employees

annually, 435 at the large and 17 at the small establishments.48

The additional annual training cost for new employees was

estimated to also be similar to the costs of HACCP training.

Therefore, FSIS estimates the combined annual training costs due

to turnover to be approximately $0.25 million (452 x $549), with

large establishments accounting for approximately $0.24 million

(435 x $549) and small establishments accounting for

approximately $9,333 (17 x $549), Table 7.

FSIS assumes that 1,080 (1,532 x 0.705) retained employees,

1,041 at the large and 39 at the small establishments, will

48 This estimate was rounded up. This analysis uses the industry turnover rate for non-durable manufactured goods to estimate separations. Source: BLS Economic News Release Table 16. Annual total separations rates by industry and region, not seasonally adjusted. <https://www.bls.gov/news.release/archives/jolts_03162017.htm> Accessed on 12/04/18. Last updated on 3/16/17.


128

require annual continuing education. This analysis assumes

annual continuing education costs to be similar to annual HACCP

refresher training costs, which range from $12 to $36 per

employee, with a mid-point of $24.49 Using the mid-point value,

this analysis estimates the combined average recurring cost for

continuing education is $25,920 (1,080 x $24), with large

establishments accounting for approximately $24,984 (1,041 x

$24) and small establishments accounting for approximately $936

(39 x 24).

Under the assumed adoption rate as set forth in Table 6,

annualized wages and training cost to industry for staffing

additional online personnel is approximately $16.61 million,

applying a 3 percent discount rate50 over 10 years, Table 7. The

majority of this cost is attributed to wages and benefits, Table

7.

Table 7: Establishment Labor Costs (M$)


Type of Expense

Number of Personnel

One- Time Cost

Recurring Cost

Large Wages 369 $20.65

Initial Training 1,476 $0.81

49 Viator, C. Et. Al. 2015. Costs of Food Safety Investments. Table 4-4. Training Costs for Management and Production Employees. 50 As is explained in Circular A-4, a discount factor should be used to adjust the estimated benefits and costs for differences in timing. For regulatory analysis, net benefit estimates should be provided using a 3 percent and 7 percent discount rate. Source: Circular A-4, OMB, September 17, 2003, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf


129

Training Due to Labor Turnover 435 $0.24

Continuing Education 1,041 $0.02

Small

Wages 14 $0.71

Initial Training 56 $0.03 Training Due to Labor Turnover 17 $0.009

Continuing Education 39 $0.001

Totals One-Time $0.84

Recurring Cost $21.63 Annualized Costs, Assuming a 3% Discount

Rate Over 10 Years $16.61 Annualized Costs, Assuming a 7% Discount

Rate Over 10 Years $15.97

b. Costs of Capital Improvements

The NSIS may require a minor capital improvement if the

establishment does not already provide a mirror at the carcass

inspection station. All the large high-volume establishments are

already required to provide mirrors under existing regulations.

The following analysis excludes further consideration of the

costs of requiring a mirror due to its minor potential cost for

a limited number of establishments.51 If an establishment

51 The cost was estimated to be very small because all 22 large high-volume establishments and potentially several of the 13 small high-volume establishments are already required to provide mirrors. As such, any new expense would be negligible compared to the industry costs included in the analysis.


130

believes that additional capital expenditures will result in a

benefit, they may voluntarily reconfigure or update their

facilities to fully capture all the potential production

efficiencies offered through participation in the NSIS. Examples

of such changes include line reconfiguration, which can cost

between $10,000 to $250,00052 and the creation of an inspection

station, which can cost between $5,000 and $6,000.53

Establishments may reduce these costs by coordinating these

facility updates with previously planned establishment

renovations.

c. Costs of Developing Ante-Mortem Written Procedures

Under the final rule, establishments operating under the

NSIS are required to develop and maintain in their HACCP systems

(HACCP plans, sanitation SOPs, or other prerequisite programs)

written procedures for the segregation, identification, and

disposition of animals suspected of having one of the

condemnable generalized diseases or conditions listed in 9 CFR

309. This analysis assumes establishments will coordinate this

work and costs with the development of written procedures to

prevent the contamination of carcasses and parts by enteric

52 In a May 2004 study, ERS estimated the cost of compliance per establishment with the PR/HACCP rule. Capital expenditures in Hog Slaughter establishments were estimated to be $251,800. Ollinger, Moore, Chandran (2004). Meat and Poultry Establishments’ Food Safety Investments. USDA, Economic Research Service. 53 Modernization of Poultry Slaughter Inspection; Final Rule, 79 FR. 49566 (2014).


131

pathogens, and visible fecal material, ingesta, and milk

throughout the entire slaughter and dressing operation, a

mandatory component of the final rule. Details of these costs

can be found in the sanitary dressing costs section III.G.2.a.

d. Costs Associated with Ready-to-Cook Pork Standards

Under the final rule, establishments operating under the

NSIS are required to collect, record, and analyze documentation

to demonstrate that the products resulting from their slaughter

operation meet the definition of RTC pork products. This

analysis estimates the labor costs to collect, record and

analyze such documentation under two assumptions. First, FSIS

assumes that establishments will assign the task to a quality

control (QC) technician, with an hourly compensation rate, which

includes wages, benefits, and overhead, of $68.52.54,55 Second,

FSIS assumes that this work will take 1 hour at a large

establishment and ½ hour at a small establishment per day. As is

explained in the Draft Market Hogs HIMP paper56, large swine

establishments can verify they meet OCP performance standards by

54 BLS Occupational Employment Statistics, Occupational Employment and Wages, May 2016. 19-1021 Food Scientist and Technologist. <https://www.bls.gov/news.release/archives/ocwage_03312017.pdf>. Accessed on 12/04/18. Last Modified 3/31/2017. 55 To be consistent with analyses done by the Department of Health and Human Services, this analysis accounts for fringe benefits and overhead by multiplying wages by a factor of 2. 56 Draft Market Hogs HIMP (HACCP-Bases Inspection Models Project). Draft 6/21/05. <https://www.fsis.usda.gov/wps/wcm/connect/d6ccbad7-59e0-43f5-bf54-1987152ccfe8/HIMP_Market_Hog.pdf?MOD=AJPERES>


132

taking 24 unit samples, requiring roughly 1 hour to collect,

record, and analyze the data. Based on information obtained

through PHIS, the average large swine establishment operates 269

days per year. This equates to an annual cost of approximately

$18,432 (269 x 1 x $68.52), or approximately $0.41 million for

all 22 non-HIMP establishments ($18,432 x 22). Similarly, the

cost to an average small establishment, which based on data

obtained through PHIS operates 244 days a year, is approximately

$8,359 (244 x 0.5 x $68.52), or approximately $0.11 million for

all 13 small establishments ($8,359 x 13). Combined, under the

assumed adoption rate as set forth in Table 6, these costs are

expected to increase NSIS establishments’ annual labor costs by

approximately $0.39 million, applying a 3 percent discount rate

over 10 years, Table 8.

Table 8: Cost of RTC Requirements (M$) Recurring

Type of Market Hog Only Establishment No. of Establishments Labor

Large 22 $0.41 Small 13 $0.11

Totals* Recurring Cost $0.51

Annualized Costs, Assuming a 3% Discount Rate Over 10 Years $0.39


* Note, some of the totals may not equal the sum due to rounding.


133

2. Costs Associated with Requirements for all Swine Slaughter

Establishments

The mandatory costs of the final rule will apply to all 612

swine slaughter establishments and begin on the effective date

for these requirements. These costs are associated with a)

written procedures to prevent visible fecal material, ingesta,

and milk contamination; and b) sampling and analysis for

microbial organisms to monitor process control for enteric

pathogens.

a. Costs of Developing, Composing, Training, Monitoring,

Recording, and Verifying Written Sanitary Dressing Plans

Under the mandatory portion of the final rule affecting all

Federally inspected establishments that slaughter swine, FSIS is

requiring that all official swine slaughter establishments

develop, implement, and maintain in their HACCP systems written

procedures to prevent the contamination of carcasses and parts

by enteric pathogens, and visible fecal material, ingesta, and

milk throughout the entire slaughter and dressing operation.

This cost component for establishments includes: (1) developing

and incorporating these procedures into their food safety

system, (2) training, and (3) monitoring, recordkeeping, and


134

verification. This analysis assumes 606 swine establishments

will incur these costs.57

Costs for Developing and Composing a Written Sanitary Dressing

Plan

FSIS assumes incorporating written sanitary dressing plans

into an establishment’s HACCP system will result in a one-time

HACCP plan reassessment cost. According to RTI’s Costs of Food

Safety Investments report,58 the mid-point costs of a HACCP plan

reassessment for large establishments is $730, the mid-point

costs for small and very small establishments is $365.59 The cost

to large establishments is approximately $16,060 (22 x $730),

small establishments is approximately $38,325 (105 x $365), and

very small establishments is approximately $174,835 (479 x

$365). The annualized costs to industry with a 3 percent

discount rate for all 606 swine slaughter establishments is

approximately $0.03 million, Table 9.

Table 9: Written Sanitary Dressing Plan Development (M$)

HACCP Size Number of

Establishments One-Time Cost

57 One corporation has informed FSIS, through public comment, that all six of its swine harvest facilities have written sanitary dressing plans. As such, they were not included in this portion of the cost analysis, which reduced annual costs by roughly $87,000 as compared to the proposed rule. 58 Viator, C. Et. Al. 2015. RTI International collected data on the cost of food safety investments for the production of meat and poultry products at the pre-harvest and slaughter and processing stages. This data was provided to FSIS in a final report titled ‘Costs of Food Safety Investments’ and was prepared by Catherine L. Viator, Mary K. Muth, and Jenna E. Brophy. The contract number is No. AG-3A94-B-3-0003. The order number is AG-3A94-K-14-0056. 59 Viator, C. Et. Al. 2015. Table 4-1. Costs of HACCP Plan Development, Validation and Reassessment per HACCP.


135

Large 22 $0.02 Small 105 $0.04

Very Small 479 $0.17 Totals

One-Time Cost $0.23 Annualized Costs, Assuming a 3%

Discount Rate Over 10 Years $0.03 Annualized Costs, Assuming a 7%

Discount Rate Over 10 Years $0.03

Costs for Training Establishment Personnel on Executing a

Written Sanitary Dressing Plan

FSIS assumes training programs will be utilized to ensure

that establishment personnel understand and can execute the

sanitary dressing plan. This training includes a one-time

initial training cost to the establishment, a recurring cost of

training new hires due to separations, and the cost of

conducting annual refresher training. This portion of the model

is informed by the RTI Costs of Food Safety Investments report.60

As is noted in the RTI report, these costs are based on the

amount of time a panel of experts recommends establishments

spend on training, which may exceed the amount of time

establishments spend on training. Due to data limitations, this

analysis assumes the number of establishment employees

conducting sanitary dressing tasks at swine establishments is

equal to the number of employees conducting sanitary dressing

60 Viator, C. et. al. 2015.


136

tasks at beef slaughter establishments.61 This is likely an

overestimate because unlike beef, the majority of swine are

scalded, de-haired, and polished prior to opening the carcass,

which decreases the need for employees to conduct sanitary

dressing tasks.

As seen in Table 10, costs are shared across HACCP sizes,

with large establishments incurring higher costs. The rate of

new hires, 29.5 percent, is derived from the BLS, 2016 Turnover

Rate for Non-Durable Manufacturing Goods.62 Likewise, the

retention rate for the refresher training is one minus the

turnover rate. The total one-time cost to train the employees

for all 606 establishments is roughly $1.00 million, while the

total recurring costs is roughly $0.44 million, Table 10. The

annualized costs with a 3 percent discount rate over 10 years

for Sanitary Dressing task related training is $0.55 million,

Table 10.

Table 10: Sanitary Dressing Training Costs (M$) Training Costs

One- Time Recurring

HACCP Size


Average No. of Employees Initial

New Hires Refresher

61 The Survey is at: http://www.fsis.usda.gov/wps/wcm/connect/184a3baa-2f73-4651-8aba-68124580f4e0/Pathogen_Controls_in_Beef_Operations_Survey.pdf?MOD=AJPERES. The survey report is at: http://www.fsis.usda.gov/wps/wcm/connect/6d37a1fc-a3e1-40b6-90cc-719bdb391522/STEC_Survey_Comments_Summary.pdf?MOD=AJPERES. 62 Source: BLS Economic News Release Table 16. Annual total separations rates by industry and region, not seasonally adjusted. <https://www.bls.gov/news.release/archives/jolts_03162017.htm> Accessed on 12/04/18. Last updated on 3/16/17.


137

Large 22 179 $0.48 $0.14 $0.07 Small 105 25 $0.32 $0.09 $0.04

Very Small 479 3 $0.20 $0.06 $0.03

Totals* One-Time Cost $1.00 Recurring Cost $0.44




Cost of Monitoring, Recordkeeping, and Verification Associated

with the Written Sanitary Dressing Plan

This analysis also estimates the annual monitoring,

recordkeeping and verification costs associated with maintaining

sanitary dressing procedures. This analysis assumes it will take

a production employee 5 minutes to monitor and 5 minutes to

maintain records for the sanitary dressing procedures, for a

total of 10 minutes. Establishments are required to verify the

plan each day of production. In addition, this analysis assumes

it will take a QC manager 15 minutes to perform a verification

task and that such task will be completed each week that

slaughter takes place. Combined, these tasks are estimated to

cost the entire industry roughly $0.84 million annually,

applying a 3 percent discount rate over 10 years, Table 11.

Table 11: Monitoring, Recordkeeping and Verification Costs (M$)


138

Recurring Costs

HACCP Size Monitoring Record-keeping Verification Combined

Large $0.01 $0.01 $0.03 $0.05 Small $0.04 $0.04 $0.12 $0.20

Very Small $0.07 $0.07 $0.44 $0.58 Totals*

Recurring Cost $0.84 Annualized Costs, Assuming a 3% Discount Rate

Over 10 Years $0.84 Annualized Costs, Assuming a 7% Discount Rate

Over 10 Years $0.84 * Note, some of the totals may not equal the sum due to rounding.

Summary Costs of Written Sanitary Dressing Procedures

Table 12 provides an overview of the one-time and recurring

costs associated with requiring all establishments to develop

written sanitary dressing procedures. Combined, these tasks are

expected to cost the industry $1.41 million annualized, assuming

a 3 percent discount rate over 10 years, Table 12.

Table 12: Summary of Costs Associated with Requiring Written Sanitary Dressing Procedures (M$) One-Time Costs Recurring Costs

HACCP Size

No. Of Establishments Development

Initial Training Training

Monitoring, Recording, Validating

Large 22 $0.02 $0.48 $0.21 $0.05 Small 105 $0.04 $0.32 $0.14 $0.20

Very Small 479 $0.17 $0.20 $0.09 $0.58

Totals* One-Time Cost $1.23 Recurring Cost $1.27



139



b. Cost of Carcass Sampling and Analysis for Microbial Organisms

This section reviews the potential changes in costs

associated with the alterations to microorganism testing. These

costs are limited to the changes associated with removing the

requirement that swine establishments test carcasses for generic

E. coli and replacing it with new testing requirements described

above. While the final rule also removes the codified Salmonella

pathogen reduction performance standards for swine, because the

codified standards are already no longer in use, there are no

potential costs or benefits to industry. Such changes fall under

four categories: sampling plan reassessment, transferring from

prescriptive to process testing requirements, sampling rates,

and sample recordkeeping. This analysis uses results from the

RTI International Meat Industry Survey in Support of Public

Health Risk-Based Inspection report63 and Costs of Food Safety

Investments report.64 Each of these categories is explained in

63 Viator, C. et. al. 2015. (a) RTI International designed and conducted surveys on industry practices to control pathogens and promote food safety. The sample design, administration procedures, analysis and results were provided to FSIS in a final report titled ‘Meat Industry Survey in Support of Public Health Risk-Based Inspection’ and was prepared by Catherine Viator, Sheri C. Cates, Shawn A. Karns, Peter Siegel, Ariana Napier, and Mary K. Muth. The contract number is No. AG-3A94-B-13-0003. The order No. is AG-3A94-K-13-0053. 64 Viator, C. et. al. 2015. (b)


140

detail below. Based on industry comment on the proposed rule,

this analysis excludes the 11 large swine establishments that

were participating in the SIP program when data for this

analysis was collected. Under SIP, these establishments

currently sample at an alternative frequency and we assume that

they will continue to do so. As such, these 11 SIP swine

slaughter establishments are not expected to change their

process control sampling and will not experience a change in

associated costs.

Cost of Process Control Sampling Plan Reassessment

This analysis assumes establishments will incur one-time

costs of conducting a process control sample plan reassessment

under the final 9 CFR 310.25(a)(2)(i). The RTI Costs of Food

Safety Investments report estimates the costs of reassessing a

microbiological sampling plan. For large establishments, these

costs include labor, consultant fees, and travel expenses, which

combined range from $27,320 to $81,960, with a midpoint of

$54,640 per establishment. Costs to small and very small

establishments are limited to labor expenses and range from $122

to $365, with a midpoint of $243 per establishment.65 The

annualized reassessment cost to industry is roughly $0.12

65 The report classifies establishments as either large or small. Given this data limitation, this analysis assumes very small and small establishments have similar reassessment costs.


141

million, assuming a 3 percent discount rate over 10 years, Table

13.

Table 13: Cost of Process Control Sampling Plan Reassessment (M$)

HACCP Size No. of

Establishments

Per Establishment (Mid-Point Estimate)*

Total One-Time Costs

Large 17 $0.05 $0.93 Small 105 $243 $0.03

Very Small 479 $243 $0.12 Totals**

One-Time Cost $1.07 Annualized Costs, Assuming a 3% Discount

Rate Over 10 Years $0.12 Annualized Costs, Assuming a 7% Discount

Rate Over 10 Years $0.14 *The values for Small and Very Small Establishments are in dollars. ** Note, some of the totals may not equal the sum due to rounding.

Cost of Transferring from Prescriptive to Process Specific

Microbiological Testing Requirements

Prior to the final rule, regulations prescribed that each

slaughter establishment test for generic E. coli.66 In addition

to mandated generic E. coli testing, many establishments

voluntarily conduct additional microbiological testing to verify

process control. Common microbiologic tests include APC, total

plate count (TPC), and total coliforms. Based on the meat

slaughter survey conducted by RTI, roughly 71 percent of very

66 9 CFR 310.25 (2018)


142

small, 80 percent of small, and 100 percent of large

establishments conduct microbiological testing in addition to

testing for generic E. coli.67 Establishments voluntarily

conducting additional testing are an indication that the generic

E. coli testing is not the best means to verify process control

in their respective establishments.

This analysis assumes that, if permitted to choose a

microbiological test to ensure process control, establishments

will select the single best test that demonstrates process

control at their establishment. Under these assumptions,

establishments that currently test for generic E. coli and

conduct at least one other type of microbiological test will

stop testing for generic E. coli. As a result, the 17 large (17

x 1.00), 41 small high-volume (51 x .80), 43 small low-volume

(54 x .80), 4 very small high-volume68 (6 x .714), and 338 very

small (473 x .714) establishments that currently test for

generic E. coli and at least one other microbial or pathogen

indicator69 will experience a cost reduction. Given the

67 Viator, C. et. al. 2015. (a) P5-42. Question 3.1. 68 Very small high-volume establishments slaughter more than 20,000 swine, or a combination of swine and other livestock exceeding 6,000 cattle and 20,000 total of all livestock. 69 Question 3.1 from the Meat Industry Survey in Support of Public Health Risk-Based Inspection Report asks “In addition to the generic E. coli testing of carcasses and Listeria testing of ready-to-eat (RTE) products required by FSIS regulation, does this establishment conduct microbiological testing?”; 28.6% of very small, 20% of small, and 0% of large establishments responded no, meaning 71.4% of very small, 80% of small and 100% of large establishments conduct additional testing.


143

similarity in laboratory testing costs and costs associated with

switching sampling programs, this analysis assumes the remaining

158 establishments that exclusively test for generic E. coli

will continue to do so.

Calculating the cost reductions is a function of estimating

the testing rate and testing costs. This analysis assumes all

large, small, and very small high-volume,70 establishments

conduct 1 test, every 1,000 carcasses, and all low-volume

establishments conduct 13 tests annually.71 To calculate testing

costs, this analysis estimates the associated labor expenses,

laboratory fees, and shipping costs. The mean cost to an

establishment to test a single generic E. coli sample in house

is $25.97.72 To have the sample tested at a contracted lab, the

cost is $49.81.73 Based on survey results, this analysis assumes

79 percent of large, 28 percent of small and 5 percent of very

small establishments test in house.74 For these 443

establishments, the combined reduction in testing costs of no

longer being required to test for generic E. coli was estimated

70 Note that the 11 large establishments participating in SIP have been excluded from this analysis because they have an alternative sampling frequency. 71 9 CFR 310.25(a)(2)(iii) (B). The current regulation (9 CFR 310.25(a)(2)(v)) defines very low-volume swine slaughter establishments as slaughtering 20,000 head annually or fewer. For the purposes of this analysis, FSIS has labeled swine establishments that annually slaughter more than 20,000 head per year as high volume. 72 Viator, C. et. al. 2015. (b) Table 5-1 73 Viator, C. et. al. 2015. (b) Table 5-1 74 Viator, C. et. al. 2015. (b)


144

to reduce annual testing costs by approximately $2.69 million,

assuming a 3 percent discount rate over 10 years, Table 14.

Table 14: Recurring Costs (Savings) From No Longer Requiring Generic E. coli Testing (M$)

HACCP Size No. of

Establishments (Savings) Large 17 ($2.04)

Small High-Volume 41 ($0.40) Small Low-Volume 43 ($0.02)

Very Small High-Volume 4 ($0.01) Very Small Low-Volume 338 ($0.21)

Totals Recurring Cost ($2.69)

Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ($2.69)



Process Control Sampling Rates

The final rule requires large, small, and very small high-

volume establishments to take carcass samples at pre-

evisceration and post-chill (for hot-boned products carcass

samples must be taken pre-evisceration and after the final

wash), which will increase the number of samples taken from 1

sample per 1,000 carcasses to 2 samples per 1,000 carcasses for

large, small, and very small high-volume establishments. The

final rule does not require low-volume establishments to

increase their sampling rates. Under the final regulations,


145

large establishments’ annual process control sampling costs were

estimated to increase by roughly $1.46 million, which is roughly

$85,745 per establishment ($1.46 million / 17)75, Table 15. Small

high-volume establishments’ annual process control sampling

costs were estimated to increase by roughly $0.30 million, which

is roughly $5,974 ($0.30 million / 51) per establishment, Table

15. Very small high-volume establishments’ annual process

control sampling costs were estimated to increase by roughly

$8,890, which is roughly $1,482 ($8,890 / 6) per establishment,

Table 15.

Cost of Process Control Sample Recordkeeping

This analysis takes into consideration the increase in

recordkeeping costs associated with an increase in the sampling

rate from 1 to 2 samples per 1,000 head. According to PHIS data,

the average large non-SIP establishment slaughters approximately

3.87 million swine per year. As such, this analysis estimates

that a large non-SIP establishment currently takes approximately

3,869 samples annually (3,869,276 / 1,000). The average small

high-volume swine establishment slaughters 0.23 million swine

per year and requires approximately 229 samples (228,784 /

1,000) annually. While the average very small high-volume

establishment slaughters 51,925 swine per year and requires

75 Values in text may differ because of rounding.


146

approximately 52 samples (51,925 / 1,000) annually. Assuming it

takes 2.5 minutes to record the results of each sample, the

average large establishment currently requires 9,673 minutes

(2.5 x 3,869) per year; the average small high-volume

establishment currently requires 573 minutes (2.5 x 229) per

year; and the average very small high-volume establishment

currently requires 130 minutes (2.5 x 52) per year. Requiring

establishments to increase their sampling rates from 1 to 2

samples per 1,000 head will increase the average large non-SIP

establishment’s annual number of samples to 7,738 samples

annually (3,869,276 / 1,000 x 2), which will require

approximately 19,346 minutes (2.5 x 7,738)76 annually. The same

requirement will increase a small high-volume establishment’s

annual sampling to 458 (228,784 / 1,000 x 2), which will require

approximately 1,145 minutes (2.5 x 458) annually. Likewise, a

very small high-volume establishment’s annual sampling will

increase to 104 (51,925 / 1,000 x 2), which will require

approximately 260 minutes (2.5 x 104) annually. As such, the

estimated additional time required for recordkeeping is

approximately 9,673 minutes (19,346 – 9,673) for large non-SIP

establishments; 572 minutes (1,145 – 573) for small high-volume

establishments; and 130 minutes (260 – 130) for very small high-

76 Values in text may differ because of rounding.


147

volume establishments. Assuming a quality control technician

with a compensation rate of $68.52 per hour77,78 conducts this

work, the additional costs to the average large non-SIP

establishment is approximately $11,046 (9,673/60 x $68.52).

Similarly, the additional cost to the average small high-volume

and very small high-volume establishment is approximately $653

(572 / 60 x $68.52) and $148 (130 / 60 x $68.52, respectively).

Scaling this up to all impacted establishments, the total

increase in costs to all large non-SIP establishments is

approximately $0.19 million ($11,046 x 17); $0.03 million ($654

x 51) for small high-volume establishments; and $888 ($148 x 6)

for very small high-volume establishments, Table 15.

The combined annualized sampling and recordkeeping cost to

all large non-SIP, small, and very small high-volume

establishments is roughly $1.99 million, applying a 3 percent

discount rate over 10 years. Large establishments will

potentially incur the majority of this cost, Table 15.

Table 15: Costs Changes Associated with Increase Sampling Rates (M$) No. Of

Establishments Costs

Sampling Recordkeeping Combined* 77 BLS Occupational Employment Statistics, Occupational Employment and Wages, May 2016. 19-1021 Food Scientist and Technologist. < https://www.bls.gov/news.release/archives/ocwage_03312017.pdf> Accessed on 12/04/18. Last Modified 3/31/2017. 78 To be consistent with analyses done by the Department of Health and Human Services, this analysis accounts for benefits and overhead by multiplying wages by a factor of 2.


148

Large non-SIP 17 $1.46 $0.19 $1.65 Small High-

Volume 51 $0.30 $0.03 $0.34 Very Small High-Volume (Dollars) 6 $8,890 $888 $9,778

Totals Recurring Cost $1.99




Summary of Process Control Sampling Cost Changes

Overall, the changes in sampling requirements under the

final rule were estimated to reduce industry wide sampling costs

by about $0.57 million annualized over 10 years, applying a 3

percent discount rate, Table 16. However, only the 443

establishments that currently conduct multiple types of

microbiological tests will potentially experience a reduction in

cost. The remaining establishments, roughly 158 small and very

small establishments, will potentially incur a portion of the

one-time costs associated with plan reassessment, Table 16. Cost

increases associated with testing and recordkeeping will be

exclusively borne by large, small, and very small high-volume

establishments.

Table 16: Summary of Changes to Process Control Sampling (M$) Cost (Savings)

Type of Change One-Time Recurring Plan Reassessment $1.07 -


149

Converting to Process Control Sampling - ($2.69)

Testing Costs - $1.77 Recordkeeping - $0.22

Totals* One-Time Cost $1.07 Recurring Cost ($0.70)




Summary of Voluntary and Mandatory Costs for Final Rule

The total annualized value of all costs to industry, under

the assumed five-year adoption rate as shown in Table 6, is

roughly $17.83 million, assuming a 10-year annualization and a 3

percent discount rate, Table 17. Large establishments that

voluntarily switch to the NSIS incur the majority of costs. For

example, the recurring labor costs associated with the NSIS is

the single largest recurring cost to industry and is mostly

incurred by large establishments. It should be noted that the

five HIMP pilot study establishments have already incurred these

costs, suggesting for those five establishments, the benefits of

the NSIS outweigh the costs. It also suggests that the benefits

of adopting the NSIS outweigh the costs for other establishments

as well. Training staff accounts for the bulk of the costs

associated with written sanitary dressing procedures. Sampling


150

costs will potentially decrease for those establishments that

currently conduct microbiological tests in addition to generic

E. coli.

Table 17: Combined Costs to Industry (M$)

Type of Cost No. of

Establishments

Total Costs One-Time Recurring

Voluntary Establishment Labor 35 $0.84 $21.63 Ready to Cook 35 $0.51 Mandatory Written Sanitary Dressing Procedures 606 $1.23 $1.27 Process Control Sampling 601 $1.07 ($0.70)

Totals* Number of Establishments** 612

One Time Cost $3.14 Recurring Cost $22.72



Totals Mandatory*

Number of Establishments** 612 One-Time Cost $2.30 Recurring Cost $0.58



Totals Voluntary*

Number of Establishments 35 One-Time Cost $0.84 Recurring Cost $22.15




151

* Note, some of the totals may not equal the sum due to rounding. ** Note, 612 includes all swine slaughter establishments, including the 11 SIP establishments that were excluded from the process control sampling costs and the 6 establishments that were excluded from the written sanitary dressing plans costs.

H. Potential Benefits of the Final Rule

1. Potential Benefits Associated with Public Health

Switching existing FSIS inspection program personnel (IPP)

activities toward more offline verification activities (e.g.,

sanitation performance standards, sampling, fecal inspections,

and other inspection requirements) is unlikely to result in a

higher prevalence of Salmonella on market hog carcasses and is

estimated to result in a lower prevalence of Salmonella on

market hog carcasses, which in turn may lead to fewer human

illnesses. This conclusion is supported by a two-part risk

assessment which compares typical FSIS market swine inspection

outcomes with the outcomes observed in a small subset of

establishments that participated in the HIMP pilot study

(referred to in the risk assessment as HIMP plants).

Stage 1 of the risk assessment consists of a multiple regression

analysis to identify the relationships between establishment

characteristics (including HIMP status) and carcass

contamination prevalence. FSIS presents two different models for

estimating the potential for avoiding illnesses in the risk


152

assessment one using only empirical data and one using

additional simulated data, see Tables 13 and 14 in the risk

assessment and accompanying text. The results of the modeling

with simulated data, had less uncertainty around the estimated

change in illnesses — are not used in support of the final rule.

The modeling without simulated data is carried through in this

section. As a result, the uncertainty around estimated illnesses

avoided is greater; however, the most likely estimated illnesses

avoided are not affected. Stage 2 of the risk assessment

consists of multiple scenario models in which combinations of

plausible changes to inspection procedures are inserted into

equations created using the coefficients computed in Stage 1.

These scenarios produce estimates of changes in carcass

contamination prevalence under the inspection procedures of

NSIS.

Changes in estimated numbers of Salmonella illness are

estimated based on a proportional relationship between carcass

contamination prevalence and illnesses that has been published

in the peer-reviewed literature.79,80 This relationship was also

validated internally in the risk assessment, with an analysis of

79 Williams M. S., Ebel, E. D., Vose, D. 2011. Framework for Microbial Food-Safety Risk Assessments Amenable to Bayesian Modeling. Risk Analysis 31(4):548-565. 80 Ebel, E. E., et al. 2012. Simplified framework for predicting changes in public health from performance standards applied in slaughter establishments. Food Control 28(2): pp. 250 257.


153

variance (ANOVA) test indicating that carcasses slaughtered in

establishments with relatively low prevalence of Salmonella did

not show significantly different contamination load (measured by

enumeration of Salmonella colony-forming units per gram) when

compared with establishments with relatively high prevalence of

Salmonella. In other words, the proportion of contaminated

carcasses is more predictive of Salmonella illnesses than the

contamination load of each contaminated carcass; thus, if the

proportion of carcasses with no detectable Salmonella

contamination increases with implementation of the NSIS,

illnesses caused by consumers’ exposure to these carcasses were

estimated to decrease proportionally.

As with any risk assessment, FSIS’s risk assessment relies

on a number of assumptions. FSIS assumed that the differences

between the process of slaughtering hogs and slaughtering

poultry do not alter the relationship between the presence of

Salmonella contamination post-slaughter and human illness.

FSIS also assumed, for the purpose of this risk assessment,

that the relationship between Salmonella contamination of hog

carcasses and downstream products such as pork parts (e.g., pork

chops) and ground pork closely mirrors that of the established

relationship between Salmonella contamination of poultry (e.g.,

chicken) carcasses and downstream products such as chicken parts

and ground chicken. While FSIS did not conduct any specific


154

analyses to examine this assumption, the Agency has conducted

numerous peer-reviewed analyses of the relationship between

Salmonella contamination frequency on chicken carcasses and

chicken parts.81 These analyses indicate that the prevalence of

Salmonella contamination on downstream products (e.g., parts)

often exceeds that for the prevalence of Salmonella

contamination in upstream products (e.g., carcasses). The higher

prevalence is logical given that samples of downstream products

contain primals from multiple carcasses, increasing the

likelihood of a single sample being contaminated.

The market hog Salmonella illness risk model estimates that

the prevalence of Salmonella detected in carcasses may decline

on average from an initial prevalence of 0.9407% to a final

prevalence of 0.9066% if the 35 identified establishments adopt

the new inspection system. This decrease in prevalence should

correspond to an average decrease in illnesses due to market hog

product consumption by an average of 2,533 annual cases.82

81 Ebel, E.D., Williams, M.S., Tameru, B. (2019) Relatedness of Salmonella contamination frequency on chicken carcasses and parts when processed in the same establishment. Food Control 100: 198-203. 82 The relationship between carcass contamination prevalence and human illnesses modeled as in Williams et al., 2010, Estimating changes in public health following implementation of hazard analysis and critical control point in the United States broiler slaughter industry, Foodborne Pathogens and Disease, 9 and Ebel et al., 2012, Simplified framework for predicting changes in public health from performance standards applied in slaughter establishments, Food Control, 28.


155

More specifically, CDC applies 14 empirical, population-

adjusted, and Pert uncertainty distributions multiplicatively

modeled as Monte Carlo distributions with repeated sampling and

Bayesian characteristics to the data collected at their

surveillance sites. CDC states that the illness estimates are

robust but likely underestimates due to extrapolation from

surveillance and outbreak data with underreporting not captured

in the CDC uncertainty estimates based ultimately on laboratory

confirmed cases. CDC’s modeling approach used to estimate total

uncertainty of illnesses is designed to capture multiple sources

of uncertainty that were not explicitly modeled, that is, the

uncertainty in CDC illness estimates captures components of

consumer behavior, cross contamination and Salmonella

inactivation and growth between production and consumption.83 The

uncertainty surrounding illness estimates is the largest

contributor to overall uncertainty in the NSIS risk model. The

total uncertainty in the case rate is estimated to be bounded at

the 10th and 90th percentiles by a potential increase of 1,719

and a potential decrease of 6,685 cases, respectively. The total

case uncertainty distribution is dependent on the uncertainty in

the change in Salmonella prevalence in market hogs.

83 CDC’s surveillance and outbreak attribution data are available in Scallan, E., et al. 2011. Foodborne Illness Acquired in the United States – Major Pathogens. Emerging Infectious Diseases 17(1): 7-15.


156

The prevalence estimates are modeled with data variability

and robust uncertainty components taken from sampling data and

model parameter estimates. Additional, unquantified uncertainty

includes the possibility that differences between HIMP plants

and non-HIMP plants that adopt NSIS not accounted for in the

risk assessment could affect Salmonella prevalence. A number of

potential differences, however, are taken into account in the

risk assessment. The variability and uncertainty in the market

hog proportion of illnesses is modeled from FSIS market hog

slaughter data and Bayesian uncertainty. As demonstrated in the

2010-2011 Market Hog Baseline Study, the market hog slaughter

process resulted in 2,390,482 carcasses produced per year and a

weighted Salmonella contamination prevalence rate of 1.66%; the

10th percentile estimate for this value is 2,218,169 carcasses

and the 90th percentile estimate is 2,561,973 carcasses. This

uncertainty in the carcass prevalence rate in market hogs

according to the peer reviewed prevalence model corresponds to

the overall uncertainty in consumer Salmonella cases of

illnesses from market hogs with an average of 69,857 cases and

10th and 90th percentiles of 40,778 and 104,333 cases

respectively, under traditional inspection. With adoption of the

new inspection system, the average number of cases is likely to

decrease to 67,324.


157

The market hog risk assessment estimates that if the 35

establishments expected to convert to the NSIS over 5 years do

so, the number of human illnesses attributed to products derived

from market hogs could reduce by an average of 2,533 Salmonella

illnesses. The combined robust model estimate of quantified

uncertainty in the case rate based on CDC Salmonella illness and

FSIS market hog contamination data is estimated to be bounded at

the 10th and 90th percentiles by an increase of 1,719 and a

decrease of 6,685 cases, respectively. It is worth noting,

however, that there is an approximately 80% likelihood of a

decrease in illnesses.84 The ERS estimates of the annual per case

cost of foodborne illnesses for Salmonella range from roughly

$321 to $5,820, with a mean of roughly $3,682.85 These estimates

factor in the costs of physician office, emergency room, and

outpatient clinic visits, as well as hospitalizations,

productivity loss, and deaths. Assuming approximately 2,533

averted cases of Salmonella, potential savings range from

roughly $0.81 million to $14.74 million, with a midpoint of

$9.33 million, Table 18. Health costs would increase by roughly

84 The primary conclusion for the purposes of this regulatory change, however, is that the NSIS is unlikely to result in a higher prevalence of Salmonella on market hog carcasses and may result in a lower prevalence of Salmonella on market hog carcasses, which in turn may lead to fewer human illnesses. As such, public health benefits are characterized as “potential” rather than “expected” benefits. 85 USDA ERS, 2014, Cost Estimates of foodborne illnesses. <http://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx#48446> Accessed on 9/9/2011. Last Updated on 11/12/2014.


158

$6.33 million if cases increased by 1,719, which corresponds to

the 10th percentile, and each case cost $3,682, Table 18.

Alternatively, health costs would decrease by roughly $24.62

million if 6,685 cases were averted, which corresponds to the

90th percentile, and each case cost $3,682, Table 18. Using the

midpoint estimate of $9.33 million cost decrease and applying a

five-year adoption rate, the annualized value is approximately

$7.09 million, at a 3 percent discount rate, Table 18. These

estimated benefits may underestimate total benefits because they

do not include pain and suffering costs. They may also

overestimate benefits and cost savings given the uncertainty

between the number of illnesses and the number of carcasses with

detectable Salmonella.

Table 18: Potential Benefits from Averted Cases of Salmonella

Percentile

Change in Illnesses by Scenario

Cost Per Illness* Low Mid High $321 $3,682 $5,820

Scenario Costs, $M 10th 1,719 $0.55 $6.33 $10.01 Mean (2,533) ($0.81) ($9.33) ($14.74) 90th (6,685) ($2.15) ($24.62) ($38.91)

Comparison of Mean Recurring Costs(M$) Low

Recurring Cost $6.33 Annualized Costs, Assuming a 3% Discount Rate Over

10 Years $4.81 Annualized Costs, Assuming a 7% Discount Rate Over

10 Years $4.62 Mid

Recurring Cost ($9.33)


159



High Recurring Cost ($24.62)



*Source: USDA ERS, 2014, Cost Estimates of foodborne illnesses. <http://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx#48446> Accessed on 9/9/2011. Last updated on 11/12/2014.

Note, some of the totals may not equal the sum due to rounding. 2. Other Benefits Associated with Modernizing Existing

Regulations

The final rule will potentially reduce the regulatory

burden on establishments by shifting from prescriptive to

performance-based regulation. Based on the Evaluation of HACCP

Inspection Models Project (HIMP) for Market Hogs Report, the

five HIMP establishments’ average line speed was approximately

12.49 percent faster than comparable establishments.86 This

increase in line speed is synonymous with an increase in

industrial efficiency. To quantify the benefit associated with

this efficiency gain, this analysis used the North American Meat

86 USDA FSIS Evaluations – HACCP Inspection Models Project (HIMP) for Market Hogs https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/evaluations-+himp Accessed on 1/6/2017. Last updated on 11/14/2014.


160

Institutes’ (NAMI’s) average pork packer margins for 2013-2017,

which was reported to be $15.2087 per head in NAMI’s 2017 Meat

and Poultry Facts.88 The pork packer margin is the price the

packer receives less the cost of the hog and production costs,

making it an estimate for accounting profits. However, economic

profit may be more precisely associated with producer surplus.

Economic profit is equal to the establishment’s revenues minus

its implicit and explicit costs. Implicit costs are costs

establishments do not spend money on, such as opportunity costs,

while explicit costs are costs establishments spend money on,

such as labor or hogs. Accounting profits can be larger than

economic profits because they exclude some implicit costs. FSIS

requested, but did not receive, comment on refining this

estimate so as to distinguish between accounting profit and

economic profit.

By using accounting profits to estimate producer surplus,

this analysis multiplied the change in quantity produced by half

the per head margin, which is $7.60 ($15.20 / 2). This approach

assumes that marginal costs increases as a function of quantity

87 Note that the increase in benefits as compared to the proposed rule is due to updating the margin used from NAMI’s 2015 Meat and Poultry Facts to NAMI’s 2017 Meat and Poultry Facts. The proposed rule used a five-year average of $4.10(2010-2014) per head, with a low of a $2.85 (2012) per head loss to a $11.49 (2010) per head gain. While the Final Rule uses a five-year average of $15.20 (2013-2017) per head, with a low of a $4.50 (2013) per head gain to a $25.26 (2017) per head gain. 88 Nalivka, J. S., The 2017 Meat and Poultry Facts, NAMI August 2018.


161

produced and that the marginal cost curve is linear, in which

case the profit margin reaches zero for the last unit produced.

Assuming establishments increase their production by 12.49

percent and that this increased production has an average packer

margin of $7.60 per head, an average large establishment’s

surplus could increase by approximately $3.78 million, while an

average small high-volume establishment’s surplus could increase

by $0.34 million, all else being equal. Combined, such an

increase in efficiency at all 35 establishments will increase

producer surplus by roughly $87.64 million89 (22 x $3.78 million

+ 13 x $0.34 million), which has an annualized benefit of

roughly $66.93 million, assuming a 3 percent discount rate over

10 years, Table 19. This estimate takes into consideration the

assumed five-year adoption rate. However, this increase in

surplus may be an overestimate given that an increase in line

speeds may change market hog prices, establishment production

costs, retail prices, and export volumes. Additionally, this

analysis does not account for a change in consumer surplus,

which will be conditional on how an increase in line speed

affects retail prices. The Agency sought, but did not receive,

comment on the extent to which such an increase in line speeds

89 Note, some of the totals may not equal the sum due to rounding.


162

will affect market hog prices, establishment hours of

production, consumer prices, and export volumes.

Table 19: Industrial Efficiency, (Benefits) M$



Change in Producer Surplus Per Establishment Combined

Large 22 ($3.78) ($83.26) Small 13 ($0.34) ($4.38) Combined* 35 ($87.64)

Totals* Recurring Cost ($87.64)




The five HIMP establishments have demonstrated that

establishments operating under the NSIS are able to increase

their compliance with sanitation SOPs and HACCP regulations,

lower their level of non-food safety defects, achieve equivalent

or better Salmonella verification testing rates, and lower the

level of violative chemical residues.90 The five establishments

that participated in the HIMP pilot study account for 15 percent

of total swine production.

Additionally, the NSIS increases the Agency’s ability to

conduct more process and product verification and to increase



163

monitoring of humane handling procedures, which is expected to

improve animal welfare. FSIS inspectors devoted approximately

5.33 hours per shift to verifying humane handling activities for

the Humane Activity Tracking System, HATS, categories in HIMP

market hog establishments compared to approximately 4.29 hours

per shift in the 21 non-HIMP market hog comparison

establishments.91 Under the NSIS, establishments sort, remove,

and identify swine unfit for slaughter before FSIS ante-mortem

inspection. More FSIS resources can be devoted to offline

inspection activities because initial sorting and tagging

functions are performed by establishment personnel. This change

will provide Agency personnel with more time to conduct offline

inspection activities.

I. Potential Budgetary Impacts on the Agency

Under the final rule, FSIS will shift Agency resources from

online to offline activities. This analysis estimates how such a

shift will reduce labor expenses by approximately $6.67 million

annually, Table 20. However, Agency personnel at NSIS

establishments will require additional training, the annualized

cost of which is estimated to be approximately $0.30 million.

Both annualized estimates apply a 3 percent discount rate over



164

10 years and takes into consideration the assumed five-year

adoption period. The Agency will also update PHIS to allow

establishments to enter information on animals removed from the

slaughter process. This modernization process will likely cost

FSIS approximately $300,000 but will be paid for using existing

Agency funds. Details of these costs are provided below.

1. Agency Staffing

The following section discusses the impact on the Agency’s

budget due to reassignment of the inspection staff. As discussed

in section F of this document, under traditional inspection, a

single slaughter line at a large establishment requires up to 11

FTEs, while a small market hog establishment requires up to 2

FTEs. Under NSIS, a single slaughter line at a large

establishment will potentially require 6 FTEs, while a small

market hog establishment will potentially to require 3 FTEs.

Under NSIS, large establishments with 2 slaughter lines will

potentially require 10 FTEs92, while a small market hog

establishment with 2 slaughter lines will potentially require 4

FTEs.

This analysis considers likely staffing changes at the 22

large and 13 small establishments which will potentially convert

92 The difference in staffing between large establishments with 1 and 2 lines is because the Agency does not anticipate duplicating offline FTEs per line.


165

to NSIS over a course of five years. Combined, these

establishments operate 46 shifts and 55 lines.93 This analysis

uses PHIS data provided by the Office of Field Operations (OFO)

to calculate the number of FTEs assigned to each slaughter line.

The FSIS Office of the Chief Financial Officer (OCFO) provided

the wage and benefit data for each of these positions. This data

was used to model the staffing changes in terms of both full-

time positions and monetary value. Based on this data, to

conduct traditional inspection, the Agency requires a combined

365 (334 at large and 31 at small establishments) FTE food or

consumer safety inspectors at an annual cost of approximately

$30.43 million, Table 20. If all 22 large non-HIMP and 13 small

high-volume market hog only establishments convert to the NSIS,

the Agency will require 218 (187 at large and 31 at small

establishments) FTE food or consumer safety inspectors. This

number was arrived at by assuming that under NSIS each of the 41

lines at the large establishments will have up to 3 FTEs

assigned to them and each of the 32 shifts at the large

establishments will have up 2 FTEs assigned to them ((41 lines x

3 FTEs) + (32 shifts x 2 FTEs) = 187 FTEs). Likewise, under

NSIS, the 13 small establishments will each require between 2-3

93 The 22 large establishments operate 41 slaughter lines during 32 shifts, while the 13 small establishments operate 14 lines during 14 shifts, source PHIS.


166

FTEs, based on configuration, for a total of 31 FTEs. These

staffing levels are based on FSIS’s experience at HIMP

establishments. The combined labor costs for NSIS is

approximately $21.70 million, Table 20. This cost estimate

includes estimated grade increases associated with converting to

the NSIS. As is shown in Table 20, if all 22 large

establishments convert to NSIS, this analysis estimates a net

decrease of 147 (334 – 187) FTEs required for slaughter line

inspection. The NSIS inspection program at these large

establishments has a remuneration value of just over $18.58

million. A similar analysis of the 13 small high-volume

establishments reveals no net change in the number of FTEs.

However, because the NSIS requires all inspectors to be CSIs,

many of the FTEs will likely be promoted from a FI to a CSI.

Overall, if all 35 establishments converted to NSIS, the Agency

will require 147 fewer FTEs for swine slaughter inspection, with

potential annual decrease in costs of roughly $8.73 million,

which is equal to roughly $6.67 million a year, assuming a 3

percent discount rate and the assumed five-year adoption period,

Table 20.

Table 20: Potential Changes in Agency Staffing (M$)

Type

Traditional NSIS Increases

(Reductions)

No. Positions

Labor Costs

No. Positions

Labor Costs

No. Positions

Labor Costs


167

Large 334 $27.56 187 $18.58 (147)

($8.98) Small 31 $2.87 31 $3.12 0 $0.25

Total 365 $30.43 218 $21.70 (147)

($8.73) Totals

Recurring Cost

($8.73) Annualized Costs, Assuming a 3% Discount Rate Over 10

Years

($6.67) Annualized Costs, Assuming a 7% Discount Rate Over 10

Years

($6.42)

Since 2008, the Agency has annually lost, through

attrition, 270 food inspectors on average. See Table 21 for

details. The Agency plans to utilize all personnel made

available as a result of conversion to NSIS to fill these vacant

positions.

Table 21: Annual Turnover of Food Inspectors Fiscal Year No. Of Positions

2008 307 2009 264 2010 231 2011 268 2012 266 2013 246 2014 273 2015 305

Average 270 Source: OFO

2. Agency Training

a. Three Day NSIS Methods Course


168

If all 22 large and 13 small market hog establishments

convert to NSIS over the course of five years, as set forth in

Table 6, the Agency estimated training 266 personnel (218 CSIs

and 48 PHVs), with pay grades ranging from GS-8 to GS-13, on

NSIS methods. The majority of these personnel, 228, are

associated with 22 large establishments, while the remaining 38

are associated with 13 small establishments, Table 22. The

associated one-time cost of such training includes labor and

travel expenses associated with the employees receiving

training, as well as temporary replacement labor costs required

to fulfill the work that would have been completed by the

employees receiving training. Based on the HIMP pilot study,

this analysis assumes NSIS methods training will take 3 days and

replacement labor will be equivalent to GS-13 step 5. Under

these assumptions, the total one-time cost of NSIS training is

approximately $0.64 million ($0.56 million for all large

establishments and $0.08 million for all small establishments),

Table 22. This one-time cost equals approximately $0.07 million

if it were annualized over 10 years under a 3 percent discount

rate, Table 22.

Table 22: Three Day NSIS Training Course (M$)


Cost of Trainee Replacement Labor

Combined Costs

No. of Inspectors Requiring Training

Costs of Wages and

Benefits

No. of Replacement Inspectors Required

Costs of Wages and Benefits

for


169

for Trainees

Replacements

Large 228 $0.21 228 $0.34 $0.56 Small 38 $0.03 38 $0.06 $0.08

Totals* One-Time Cost $0.64




b. Fill an Increase Need for Consumer Safety Inspectors

Under the final rule, slaughter line inspectors at a NSIS

establishment will work both on and off the slaughter line. As

such, every inspection position will fall under the CSI position

classification. To fill the increase in demand for CSIs, the

Agency plans to train existing FIs. Training includes a four-

week meat inspector course titled Inspection Methods (IM) and a

one-day computer familiarization course. If all 22 large

establishments convert to NSIS, the Agency will need an

additional 82 CSIs. Likewise, if all 13 small market hog

establishments convert, the Agency will need an additional 16

CSIs. Converting a FI into a CSI may result in a grade increase,

the cost of which has been included in the Agency Staffing

section above. The combined one-time cost for converting FIs

into CSIs is roughly $2.16 million, Table 23. Nearly half of

this cost stems from the need for replacement labor. Again,


170

under the projected five-year adoption rate, as set forth in

Table 6, and annualized over 10 years under a 3 percent discount

rate, the cost for converting FIs to CSIs is approximately $0.23

million, Table 23.

Table 23: Cost of Converting a Food Inspector Into a Consumer Safety Inspector, (M$)

Training Component

Labor Travel, M&IE, and Lodging

Combined Costs Trainee Replacement

Four Week IM Course $0.52 $0.98 $0.59 $2.09 One Day Computer Training $0.03 $0.05 - $0.07

Totals* One-Time Cost $2.16




Combined Estimated Budgetary Impacts

The Agency’s budget will potentially be impacted both by

changes to personnel and training requirements. First, on

average, there will be fewer Agency inspection personnel per

slaughter line operating under NSIS. If all 22 large and 13

small establishments convert to NSIS over the course of five

years, the Agency will require approximately 147 fewer FTEs to

inspect the 5594 slaughter lines operating at these

establishments. The annual remuneration value of these 147

94 Source: PHIS


171

positions is roughly $8.73 million, Table 24. Second, the Agency

will need to train approximately 266 personnel on NSIS methods

at a one-time cost of approximately $0.64 million, Table 24.

Third, the Agency plans to meet the increase in demand for CSIs

by converting existing FIs into CSIs. The one-time cost of doing

so is approximately $2.16 million, Table 24. The annualized

value of the combined changes to the Agency’s budget is a net

reduction of roughly $6.38 million, over 10 years assuming a 3

percent discount rate, Table 24.

Table 24: Combined Changes to FSIS's Budget (M$)

Total Costs

One-Time Recurring Changes to Agency Staffing ($8.73) Three Day NSIS Training $0.64

Converting Food Inspectors into Consumer Safety Inspectors $2.16

Totals One-Time Cost $2.80 Recurring Cost ($8.73)



J. Net Benefits

Assuming all high-volume large and small exclusively market

hog establishments convert to NSIS (5 HIMP, 22 large, and 13

small high-volume), the rule is anticipated to have a net benefit

of approximately $62.56 million a year, annualized over 10 years


172

assuming a 3 percent discount rate, Table 25. The majority of the

costs will be incurred by the 35 non-HIMP establishments that

will potentially voluntarily switch to the NSIS in the form of

increased labor needs.

Table 25: Net Costs and (Benefits)(M$)

Number of Establishments

One-Time Recurring

Costs to Industry $3.14 $22.72 Voluntary* 40** $0.84 $22.15 Mandatory 612 $2.30 $0.58

Health Benefits*** ($9.33) Industrial Efficiency ($87.64) Impacts to Agency's Budget $2.80 ($8.73)

Totals One-Time Cost $5.94

Recurring Cost ($82.98) Annualized Costs, Assuming a 3% Discount Rate

Over 10 Years ($62.56)

Annualized Costs, Assuming a 7% Discount Rate Over 10 Years

($60.00)

* Further explanation and details on the NSIS adoption rate are provided in section G. Potential Cost of the Final Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 26: Quantified Cost and (Benefits) of Various Adoption Rates

** Note, this includes 5 HIMP establishments, which were not estimated to incur any cost or benefits associated with the NSIS *** Further explanation and details on the range of health benefits have been provided in section H. Potential Benefits of the Final Rule, Table 18: Health Benefits from Averted Cases of Salmonella. The value of health benefits ranges from a $6.33 million decrease to a $24.62 million increase in health benefits, with a mean increase in benefits of $9.33 million, assuming a cost per illness of $3,682. **** Note, some of the totals may not equal the sum due to rounding.

Given the lack of data with which to make cost-benefit

comparisons across the industry, Table 26 provides a range of

possible adoption scenarios and their corresponding costs and


173

benefits. Under scenario A, only the 5 HIMP establishments adopt

the NSIS. Because these 5 establishments are already operating

under NSIS practices, there will not be any additional voluntary

costs or benefits associated with these 5 establishments

adopting the NSIS. However, 606 establishments will incur costs

associated with the final rule’s mandatory components. As such,

scenario A has a net cost. Scenario B assesses the net cost and

benefits of just 6 establishments adopting the NSIS (5 HIMP and

1 large). This scenario reveals that the rule is net beneficial

if just 1 large establishment adopts the NSIS in addition to the

5 HIMP establishments. Scenarios C, D, and E measure the net

costs and benefits of 50, 75, and 100 percent of the 35 non-HIMP

establishments converting to the NSIS, respectively. Each of

these scenarios are net beneficial.

Table 26: Quantified Cost and (Benefits) of Various Adoption Rates (M$)^

No. to

Adopt*

Costs (Benefits)

Net Mandatory@ NSIS Health Line

Speeds Agency Budget

A 5 $0.84 $0.0 $0.0 $0.0 $0.0 $0.84

B 6 $0.84 $0.86

($0.27) ($3.78)

($0.38) ($2.73)

C 23 $0.84 $8.34

($3.59)

($33.34)

($3.14) ($30.90)

D 32 $0.84 $13.08

($5.52)

($51.51)

($4.88) ($47.99)

E 40 $0.84 $17.0

($7.09)

($66.93)

($6.38) ($62.56)


174

* These numbers include the 5 HIMP establishments. However, because these establishments are already conducting NSIS practices, they did not contribute to quantified NSIS costs, health benefits, or the impacts to the Agency's budget. @ These costs are incurred by all 612 swine establishments. ^ Annualized Assuming a 3% Discount Rate Over 10 Years * Note, some of the totals may not equal the sum due to rounding.

K. Alternatives

Table 27: Alternative Policy Options

Alternatives Benefits Costs Net

A. No action (Baseline)

1. No additional costs to industry.

1. Potential for inefficient use of agency resources.

2. No potential increase in industrial efficiency.

3. Lack of incentive for establishments to innovate and improve their process controls.

4. No potential health benefits.

B. Mandatory Portion of the Final Rule Only

1. In comparison to the baseline, potential $0.57M in Process Control Sampling cost savings.

1. In comparison to the baseline, potential $1.41M in Other Industry Costs.

Costs of $0.84M

C. Final Rule (40 Establishments Adopt NSIS)

1. Potential $7.09M in averted illnesses. 1. Potential $16.61M

Increase in Industry Labor Costs

Benefits of $62.56M 2. Potential

$66.93M in Industrial Efficiency.


175

3. Potential $0.57M in Process Control Sampling cost savings.

2. Potential $1.80M in Other Industry Costs

4. Roughly $6.67M in Agency Labor Savings.

3. Roughly $0.30M in Agency Training Costs

D. Require All 612 Establishments Adopt NSIS

1. Potentially more than $7.09M in averted illnesses. 1. Potential $25.9M

Increase in Industry Labor

Benefits of $47.59M

2. Potential $66.93M in Industrial Efficiency. 3. Potential $0.57M in Process Control Sampling cost savings.

2. Potential $3.14M in Other Industry Costs

4. Roughly $2.72M in Agency Labor Savings.

3. Roughly $0.68M in Agency Training Costs

Note, some of the totals may not equal the sum due to rounding.

A - Taking No Action (Baseline)

FSIS considered maintaining the current inspection system

for all 612 swine slaughter establishments. The Agency rejected

this alternative because it would forgo the benefits provided by

the NSIS. These benefits include the establishment’s ability to

innovate and develop process controls which increase foodborne

hazard detection and more efficiently use all their resources.

Taking no action would also forgo potential industrial

efficiency increases. Further, no action would result in the

Agency continuing to dedicate resources to food quality issues,


176

at the expense of increasing offline activities benefitting food

safety. Last, taking no action would also forgo potential health

benefits identified under the final rule.

B - The Mandatory Portion of the Final Rule

FSIS considered limiting the final rule to only include new

requirements that affect all swine slaughter establishments.

Under such a scenario, quantified benefits are limited to an

estimated $0.57 million reduction in process control sampling

costs. This cost reduction will potentially be off-set by a

$1.41 million increase in other industry costs associated with

requiring written sanitary dressing plans. In comparison to the

baseline, this scenario has a net cost of roughly $0.84 million.

Additionally, under such a scenario, the Agency’s inspection

staff would not be reassigned, and the Agency would continue to

require the same number of inspectors. As such, the Agency’s

labor costs would not decrease by the estimated $6.67 million.

However, because FIs would not be converted into CSIs nor will

inspectors require additional training, the Agency would not

incur the corresponding $0.30 million in training costs ($0.07

for NSIS training plus $0.23 in CSI training). As mentioned

earlier, simultaneously increasing unscheduled and scheduled

inspection procedures and decreasing scheduled but not performed

procedures accrues most of the public health benefits. The

unscheduled and scheduled tasks are currently not performed as a


177

result of lack of offline personnel. In comparison to the final

rule, this alternative would eliminate most of the public health

benefits associated with the rule, which are estimated at $7.09

million annually. Additionally, line speed restrictions would

remain in place, leading to an estimated loss of over $36.14

million in industrial efficiency gains. FSIS has rejected this

alternative in light of its estimated net cost as compared to

the baseline as well as the decrease in net benefits as compared

to the final rule.

C – The Final Rule

Applying a 3 percent discount rate over 10 years the costs

associated with the final rule includes $16.61 million in

additional industry labor costs, $1.80 million in other industry

costs including costs associated with meeting ready to cook

standards and written sanitary dressing plans, as well as $0.30

million in Agency training costs. The quantified health benefits

of the final rule are limited to reductions in Salmonella

illnesses and have an estimated value of $7.09 million, assuming

a 3 percent discount rate. Allowing establishments to set line

speeds so long as they maintain process control will potentially

increase their efficiency by $66.93 million, assuming a 3

percent discount rate. The final rule could potentially reduce

industry costs associated with process control sampling by

roughly $0.57 million, assuming a 3 percent discount rate.


178

Additionally, the final rule could potentially reduce the

Agency’s labor costs by roughly $6.67 million, assuming a 3

percent discount rate. In comparison to the baseline, the final

rule has an estimated net benefit of $62.56 million, assuming a

3 percent discount rate over 10 years, and as such, the Agency

recommends the final rule.

D - Requiring All Federally Inspected Establishments Adopt the

New Swine Inspection System

FSIS considered requiring all Federally inspected swine

slaughter establishments to convert to NSIS. This would expand

NSIS from the 5 large HIMP, 22 large and 13 small high-volume

non-HIMP establishments expected to convert under the final rule

to include 572 additional establishments. This expansion would

include low-volume establishments that slaughter all types of

swine as well as other establishments that slaughter a mix of

species.

In comparison to the baseline, the benefits of this

alternative potentially include more than $7.09 million in

averted illnesses, a $66.93 million increase in industrial

efficiency, $0.57 million in industrial savings associated with

process control sampling requirements, assuming a 3 percent

discount rate over 10 years. While compared to the baseline,

this alternative reduces Agency labor costs by $2.72 million,

assuming a 3 percent discount rate over 10 years. However, this


179

alternative’s Agency labor costs savings are less than the final

rule’s Agency labor costs savings because this alternative would

result in additional promotions and training in small and very

small establishments. The production at these 572 additional

establishments represents less than 8 percent of total

production and, as such, is not expected to return substantial

reductions in contamination prevalence or illnesses and falls

outside of the current risk assessment. In particular, the

uncertainty around measurement and model parameters that is

already included in the health benefit calculations for the

final rule likely produce wide enough estimates that the impact

of adopting the NSIS in all establishments would have an effect

within the uncertainty bounds. The increase in industrial

efficiency remains similar to that of the final rule because

these additional establishments are generally less automated and

maintain slower line speeds to address higher rates of quality

defects associated with non-market hogs.

In comparison to the baseline, the potential costs

associated with this alternative include a $25.90 million

increase in industrial labor, a $3.14 million increase in other

industry costs, which include costs associated with RTC

standards and written sanitary dressing plans, as well as

roughly $0.68 million in Agency training costs. In comparison to

the final rule, the additional increases in costs to industry


180

are substantially higher and predominately fall on small and

very small business. While this alternative has a net benefit of

$47.59 million, assuming a 3 percent discount rate over 10

years, the Agency rejects it because its net benefit is less

than the final rule.

IV. Regulatory Flexibility Act Assessment

The FSIS Administrator has made a determination that this

final rule will not have a significant economic impact on a

substantial number of small entities in the United States, as

defined by the Regulatory Flexibility Act (5 U.S.C. 601 et

seq.). FSIS used an establishment’s HACCP processing size, which

applies to an individual establishment, as a proxy for business

size. HACCP processing sizes are the following: large

establishments have 500 or more employees; small establishments

have between 10 and 499 employees; very small establishments

have fewer than 10 employees or annual sales of less than $2.5

million. Section III provides additional details on costs

incurred by small businesses.

The final rule’s mandatory requirements will affect

approximately 584 small entities- 105 small and 479 very small.

First, the mandatory requirements include that all small and

very small establishments create written sanitary dressing plans

with cost components of development of the plan, training of

employees, and recordkeeping, at an annualized cost of $1,869


181

per establishment, applying a 3 percent discount rate over 10

years. Second, the mandatory changes to process control sampling

requirements could potentially decrease small establishments’

sampling costs by roughly $984 per establishment annually,

applying a 3 percent discount rate over 10 years. In addition to

this sampling cost reduction, the Agency will allow small and

very small low-volume establishments to modify their sampling

plans to collect samples less frequently once they have

collected 13 consecutive weekly samples and can demonstrate that

they are not exceeding their upper control limit and that they

are effectively maintaining process control. FSIS is also

allowing establishments to develop sampling plans that are more

tailored to their specific operation, and thus more effective in

monitoring their specific process control as compared to the

current generic E. coli criteria. Therefore, the final rule’s

mandatory requirements could potentially increase small

establishments’ costs by roughly $885 ($1,869 - $984 = $885) per

establishment annually, an amount that will potentially have

little effect on small entities. To put this in perspective, the

average small and very small establishment slaughters over

21,000swine annually. Using the American Meat Institute’s

average pork packer dollars per head margins for 2013-2017, the

average small and very small establishment’s marginal revenue is

$332 thousand (21,858 (heads slaughtered) x $15.20 (average


182

margin per head)). The final rule also provides small and very

small establishments with additional time to comply with the new

requirements in 9 CFR 310.18(c) and (d). Additionally, the

optional NSIS portion of the rule could potentially provide an

overall cost savings for the 13 small high-volume establishments

of roughly $288,731 per establishment that adopts the NSIS. This

estimate takes into consideration the increase in labor cost

($42,025 per establishment), cost associated with meeting RTC

standards ($6,300 per establishments) and cost savings from

increased industrial efficiency ($337,056 per establishment).

See section III for additional details.

V. Executive Order 13771

Consistent with E.O. 13771 (82 FR 9339, February 3, 2017),

FSIS estimates that this final rule will yield cost savings.

Assuming a 7 percent discount rate, a perpetual time horizon,

and a starting year of 2019, the final rule is estimated to

yield approximately $51.91 million (2016$) in annual cost

savings, not including potential health benefits. Therefore,

this rule is an E.O. 13771 deregulatory action.

VI. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. § 801 et

seq.), the Office of Information and Regulatory Affairs

designated this rule as not a “major rule,” as defined by 5

U.S.C. § 804(2).


183

VII. E-Government Act

FSIS and USDA are committed to achieving the purposes of

the E-Government Act (44 U.S.C. 3601, et. seq.) by, among other

things, promoting the use of the Internet and other information

technologies and providing increased opportunities for citizen

access to Government information and services, and for other

purposes.

VIII. Executive Order 12988, Civil Justice Reform

This rule has been reviewed under E.O. 12988, Civil Justice

Reform. Under this rule: (1) All State and local laws and

regulations that are inconsistent with this rule will be

preempted; (2) no retroactive effect will be given to this rule;

and (3) no administrative proceedings will be required before

parties may file suit in court challenging this rule.

IX. Executive Order 13175

This rule has been reviewed in accordance with the

requirements of E.O. 13175, Consultation and Coordination with

Indian Tribal Governments. E.O. 13175 requires Federal agencies

to consult and coordinate with Indian tribes on a government-to-

government basis on policies that have tribal implications,

including regulations, legislative comments or proposed

legislation, and other policy statements or actions that have

substantial direct effects on one or more Indian tribes, on the

relationship between the Federal Government and Indian tribes,


184

or on the distribution of power and responsibilities between the

Federal Government and Indian tribes.

The USDA’s Office of Tribal Relations (OTR) has assessed

the impact of this rule on Indian tribes and determined that

this rule has minimal tribal implications. If an Indian tribe

requests consultation, FSIS will work with the OTR to ensure

meaningful consultation is provided.

X. USDA Nondiscrimination Statement

No agency, officer, or employee of the USDA must, on the

grounds of race, color, national origin, religion, sex, gender

identity, sexual orientation, disability, age, marital status,

family/parental status, income derived from a public assistance

program, or political beliefs, exclude from participation in,

deny the benefits of, or subject to discrimination any person in

the United States under any program or activity conducted by the

USDA.

How to File a Complaint of Discrimination

To file a complaint of discrimination, complete the USDA

Program Discrimination Complaint Form, which may be accessed on-

line at

http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_

combined_6_8_12.pdf, or write a letter signed by you or your

authorized representative.


185

Send your completed complaint form or letter to USDA by

mail, fax, or email:

Mail:

U.S. Department of Agriculture

Director, Office of Adjudication

1400 Independence Avenue, SW

Washington, DC 20250-9410

Fax: (202) 690-7442

E-mail: [email protected]

Persons with disabilities who require alternative means for

communication (Braille, large print, audiotape, etc.), should

contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

XI. Environmental Impact

Each USDA agency is required to comply with 7 CFR part 1b

of the Departmental regulations, which supplements the National

Environmental Policy Act regulations published by the Council on

Environmental Quality. Under these regulations, actions of

certain USDA agencies and agency units are categorically

excluded from the preparation of an EA or an EIS unless the

agency head determines that an action may have a significant

environmental effect (7 CFR 1b.4 (b)). FSIS is among the

agencies categorically excluded from the preparation of an EA or

EIS (7 CFR 1b.4 (b)(6)).


186

Establishments that operate under NSIS will be able to

slaughter and process swine more efficiently than is possible

under current regulations, leading to a reduction in production

costs. FSIS expects that consumer demand for pork products will

determine the number of swine slaughtered rather than production

costs. Because of the efficiencies in the NSIS, the price of

pork products may decrease. The predicted price reduction could

lead to a slight increase in demand for pork products. With the

slight increase in pork product sales, some establishments may

choose to increase the number of swine slaughtered, which could

result in an increase in the number of condemned carcasses and

parts that must be disposed of. However, because the anticipated

change in price and sales is very small, especially in

comparison to changes in price and sales in response to other

market forces, the Agency has determined that the change in the

number of swine slaughtered, as well as the number of condemned

carcasses and parts to be disposed of, will be very small and

thus will not have a significant individual or cumulative effect

on the human environment. Therefore, this regulatory action is

appropriately subject to the categorical exclusion from the

preparation of an EA or EIS provided under 7 CFR 1b.4(b)(6) of

the USDA regulations.

XII. Paperwork Reduction Act


187

In accordance with section 3507(d) of the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information

collection and recordkeeping requirements included in this final

rule have been submitted by the Agency to OMB for approval which

has not yet been received. FSIS will collect no information

associated with this rule until the information collection is

approved by OMB.

Title: Swine Slaughter Inspection.

Type of Collection: New.

Abstract: FSIS updated the proposed rule’s information

collection assessment to reflect the changes made in the final

rule in response to public comments and to better align it with

the final cost estimates in section III. FSIS is also requiring

a new information collection burden but has reduced the total

annual burden estimate by 52,729.04 hours. The changes to the

final burden estimates incorporate the following factors:

• FSIS is requiring a new information collection burden;

specifically, the Agency is requiring market hog slaughter

establishments operating under NSIS to maintain records to

document the total number of animals and carcasses sorted

and removed per day and the reasons for their removal.

• The proposed mandatory pre-operational environmental

sampling was removed from the final rule. Therefore, these


188

time estimates were removed from the final burden

estimates.

• Establishments operating under SIP conduct process control

sampling at an alternative frequency. Therefore, these 11

establishments have been removed from the final burden

estimates.

• The final burden estimates only include the time to record

the sample results for the new process control sampling

requirements.

• The final burden estimates were updated so that the

establishment and time estimates align with the final cost

analysis in section III.

New information collection in this final rule

FSIS is requiring a new regulation that will create a new

information collection burden, in that it will require market

hog slaughter establishments operating under NSIS to maintain

records to document the total number of animals and carcasses

sorted and removed per day and the reasons for their removal.

FSIS has created a form to collect disposition data from

establishments. Establishments may provide the same information

as requested on the form electronically if it is submitted in a

format approved by FSIS. FSIS estimates this new requirement

will take establishments operating under NSIS, 5 minutes per


189

shift regardless of whether establishments complete the form or

submit the information electronically. This is a new

recordkeeping requirement that FSIS has submitted to OMB for

approval.

Estimated Annual Recordkeeping Burden for Maintaining

Records to Document the Total Number of Animals and Carcasses

Sorted and Removed per Day and the Reasons for Their Removal.

Respondents: Official market hog slaughter establishments

that operate under NSIS.

Estimated maximum number of respondents: 40.

Estimated Average Annual Number of Responses per

Respondent: Large establishments 352; small high-volume

establishments 290.

Estimated Maximum Total Potential Annual Responses: 13,282.

Estimated Total Annual Recordkeeping Burden: 1,107 hours.

Respondents

Estimated No. of Responde

nts

Average Annual No. of Responses per Respondent

Total Annual Responses

Time per

Response in Minute

s

Total

Annual

Burden

Hours

27 352 9,504 5 792


190

Large establishm

ents

Animals and

carcasses sorted and

removed and their reasons

Small high- volume

establishments

Animals and

carcasses sorted and

removed and their reasons 13 290 3,770 5 314

Total Recordkee

ping Burden for

sorting and

removing 40 332 13,274 5 1,106

Under this final rule, establishments also will have to

maintain written procedures to ensure that animals and carcasses

that have been sorted and removed for disposal do not enter the

human food supply and are properly disposed of under 9 CFR part

314. The requirement that swine slaughter establishments have

written procedures in their HACCP systems is already covered

under an approved information collection system, Pathogen

Reduction/Hazard Analysis and Critical Control Point Systems


191

(OMB control number 0583-0103). Therefore, this requirement of

this final rule will create no new burden on establishments.

Copies of this information collection assessment can be

obtained from Gina Kouba, Office of Policy and Program

Development, Food Safety and Inspection Service, USDA, 1400

Independence Avenue SW., Room 6065, South Building, Washington,

DC 20250; (202)720-5627.

Comments are invited on: (a) whether the proposed

collection of information is necessary for the proper

performance of FSIS's functions, including whether the

information will have practical utility; (b) the accuracy of

FSIS's estimate of the burden of the proposed collection of

information, including the validity of the method and

assumptions used; (c) ways to enhance the quality, utility, and

clarity of the information to be collected; and (d) ways to

minimize the burden of the collection of information, including

through the use of appropriate automated, electronic,

mechanical, or other technological collection techniques, or

other forms of information technology.

Comments on the proposed information collection may be

sent to both FSIS, at the addresses provided above, and the Desk

Officer for Agriculture, Office of Information and Regulatory

Affairs, Office of Management and Budget, Washington, DC 20253.


192

To be most effective, comments should be sent within 60 days of

the publication date of this final rule.

Information collections that were included in the proposed rule

Under this final rule, establishments operating under NSIS

are required to (1) identify animals or carcasses that

establishment personnel have sorted and removed for disposal

before FSIS inspection with a unique tag, tattoo, or similar

device, and to develop, implement, (2) maintain records to

document the total number of animals and carcasses sorted and

removed per day and the reasons for their removal, and (3)

maintain records documenting that products resulting from their

slaughter operations meet the new definition of RTC pork

product. Furthermore, each establishment operating under the

NSIS will also need to submit, on an annual basis, an

attestation to the management member of the local FSIS circuit

safety committee stating that it maintains a program to monitor

and document any work-related conditions of establishment

workers.

In addition, each official swine slaughter establishment,

regardless of the inspection system under which they operate,

will need to maintain, as part of its HACCP system, written

procedures for preventing, throughout the entire slaughter and

dressing operation, contamination of carcasses and parts by

enteric pathogens, and visible fecal material, ingesta, and


193

milk. These procedures must include sampling and analysis for

microbial organisms to monitor process control for enteric

pathogens, as well as written procedures to prevent visible

fecal material, ingesta, and milk contamination.

As mentioned above, the requirement that swine slaughter

establishments have written procedures in their HACCP systems is

already covered under an approved information collection system.

Therefore, this requirement of this final rule will create no

new burden on establishments.

The requirement that swine slaughter establishments monitor

their systems through microbial testing and recordkeeping will

create a new information collection burden. For each sample on

which a microbiological test is conducted, there is a “response”

for the establishment to record the sample result. Under the

final rule, large, small and very small high-volume

establishments will test and record microbiological results for

enteric pathogens, for carcass samples taken at both pre-

evisceration and post-chill (for hot-boned products, carcass

samples will be collected pre-evisceration and after the final

wash), at a frequency of once per 1,000 carcasses; and small and

very small low-volume establishments, 13 times a year. The small

and very small low-volume establishments do not experience an

increase in sampling under the final rule.


194

Estimated Annual Recordkeeping Burden: Swine Slaughter

Inspection.

Respondents: Official high-volume swine establishments.

Estimated Number of Respondents: 74 (17 large, 51 small

high-volume, and 6 very small high-volume).

Estimated Average Annual Number of Responses (samples) per

Respondent: Large establishments 3,869; small high-volume

establishments 229; and very small high-volume establishments

52.

Estimated Total Annual Responses: 77,764.

Estimated Total Annual Recordkeeping Burden: 3,240 hours.

Respondents

Estimated No. of Respondents



Time per Response in Minutes

Total Annual Burden Hours

Large establishments

Microbial testing data recordkeeping

17 3,869 65,773 2.5 2,741

Small high-volume establishments


51 229 11,679 2.5 487


195

Respondents

Estimated No. of Respondents





Very small high-volume establishments


6 52 312 2.5 13

Total Recordkeeping Burden for process control

74 1,051

77,764 2.5 3,240

FSIS is also requiring that market hog slaughter

establishments operating under NSIS submit on an annual basis,

an attestation to the management member of the local FSIS

circuit safety committee stating that it maintains a program to

monitor and document any work-related conditions of

establishment workers.

Estimated Annual Reporting Burden for Submitting an Annual

Attestation on Work-Related Conditions to the FSIS Circuit.

Safety Committee: Swine Slaughter Inspection.

Respondents: Official market hog slaughter establishments

that operate under NSIS.

Estimated maximum number of respondents: 40.


196

Estimated Average Annual Number of Responses per

Respondent: Large establishments 1; small high-volume

establishments 1.

Estimated Maximum Total Potential Annual Responses: 40.

Estimated Total Annual Recordkeeping Burden: 1.33 hours.

Respondents

Estimated No. of Re-spondents

Average Annual No. of Re-sponses per Respondent

Total Annual Re-sponses



Large establishments

Attestation on Work-Related Conditions

27 1 27 2 .90

Small high-volume establishments

Attestation on Work-Related Conditions

13 1 13 2 .43

Total Reporting Burden

40 1 40 2 1.33

SUMMARY OF BURDEN Swine Slaughter Inspection(with the recordkeeping burden for maintaining records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal).


197

TOTAL NO. RESPONDENTS 84

AVERAGE ANNUAL NO. RESPONSES PER RESPONDENT 1,084.33

TOTAL ANNUAL RESPONSES 91,084

AVERAGE HOURS PER RESPONSE 0.05

TOTAL ANNUAL BURDEN HOURS 4,347.33

SUMMARY OF BURDEN Swine Slaughter Inspection (without the recordkeeping burden for maintaining records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal).

TOTAL NO. RESPONDENTS 84

AVERAGE ANNUAL NO. RESPONSES PER RESPONDENT 926.24

TOTAL ANNUAL RESPONSES 77,804

AVERAGE HOURS PER RESPONSE 0.04

TOTAL ANNUAL BURDEN HOURS 3,241.33

XIII. Additional Public Notification

Public awareness of all segments of rulemaking and policy

development is important. Consequently, FSIS will announce this

Federal Register publication on-line through the FSIS Web page

located at: http://www.fsis.usda.gov/federal-register.

FSIS will also announce and provide a link to it through

the FSIS Constituent Update, which is used to provide


198

information regarding FSIS policies, procedures, regulations,

Federal Register notices, FSIS public meetings, and other types

of information that could affect or would be of interest to our

constituents and stakeholders. The Constituent Update is

available on the FSIS Web page. Through the Web page, FSIS is

able to provide information to a much broader, more diverse

audience. In addition, FSIS offers an e-mail subscription

service which provides automatic and customized access to

selected food safety news and information. This service is

available at: http://www.fsis.usda.gov/subscribe. Options range

from recalls, export information, regulations, directives, and

notices. Customers can add or delete subscriptions themselves,

and have the option to password protect their accounts.

XIV. Final Regulatory Amendments

List of Subjects

9 CFR Part 301

Meat inspection.

9 CFR Part 309

Animal diseases, meat inspection, reporting and

recordkeeping requirements.

9 CFR Part 310

Animal diseases, meat inspection.

For the reasons stated in the preamble, FSIS is amending 9

CFR Chapter III as follows:


199

PART 301 -– TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS

1. The authority citation for part 301 continues to read as

follows:

Authority: 7 U.S.C. 138-138i, 450, 1901-1906; 21 U.S.C. 601-

695; 7 CFR 2.7, 2.18, 2.53.

2. Amend § 301.2 by adding the definition of “Ready-to-cook

(RTC) pork product” in alphabetical order to read as follows:

§ 301.2 Definitions.

* * * * *

Ready-to-cook (RTC) pork product. Any slaughtered pork

product sufficiently free from bile, hair, scurf, dirt, hooves,

toe nails, claws, bruises, edema, scabs, skin lesions, icterus,

foreign material, and odor, which is suitable for cooking

without need of further processing.

* * * * *

PART 309 -– ANTE-MORTEM INSPECTION


follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

4. Add §309.19 to read as follows:

§ 309.19 Market hog segregation under the new swine slaughter

inspection system.

(a) The establishment must conduct market hog sorting activities

before the animals are presented for ante-mortem inspection.


200

Market hogs exhibiting signs of moribundity, central nervous

system disorders, or pyrexia must be disposed of according to

paragraph (c) of this section.

(b) The establishment must develop, implement, and maintain

written procedures to ensure that market hogs exhibiting signs

of moribundity, central nervous system disorders, or pyrexia do

not enter the official establishment to be slaughtered. The

establishment must incorporate these procedures into its HACCP

plan, or sanitation SOPs, or other prerequisite programs.

(c) The establishment must identify livestock that establishment

employees have sorted and removed from slaughter with a unique

tag, tattoo, or similar device. The establishment must develop,

implement, and maintain written procedures to ensure that the

animals sorted and removed from slaughter do not enter the human

food supply and are disposed of according to 9 CFR part 314.

(d) The establishment must maintain records to document the

number of animals disposed of per day because they were removed

from slaughter by establishment sorters before ante-mortem

inspection by FSIS inspectors and the reasons that the animals

were removed. These records are subject to review and evaluation

by FSIS personnel.

(e) The establishment must immediately notify FSIS inspectors if

the establishment has reason to believe that market hogs may


201

have a notifiable animal disease. Notifiable animal diseases are

designated by World Animal Health Organization.

PART 310 -– POST-MORTEM INSPECTION


follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

6. Amend § 310.1 by revising paragraph (b)(3) to read as

follows:

§ 310.1 Extent and time of post-mortem inspection; post-mortem

inspection staffing standards.

* * * * *

(b) * * *

(3) Swine Inspection. There are two systems of post-mortem

inspection: the New Swine Slaughter Inspection System (NSIS),

which may be used for market hogs, and the traditional

inspection system, which may be used for all swine.

(i) The NSIS may be used for market hogs if the official

establishment requests to use it and meets or agrees to meet the

requirements in 9 CFR 309.19 and 9 CFR 310.26. The Administrator

may permit establishments that slaughter classes of swine other

than market hogs to use NSIS under a waiver from the provisions

of the regulations as provided by 9 CFR 303.1(h). The

Administrator also may permit establishments that slaughter both

market hogs and other classes of swine to slaughter the market


202

hogs under NSIS and slaughter the other classes of swine under

traditional inspection.

(ii) Traditional inspection shall be used for swine when NSIS is

not used. The following inspection staffing standards are

applicable to swine slaughter configurations operating under

traditional inspection when NSIS is not used. The inspection

standards for all slaughter lines are based upon the observation

rather than palpation, at the viscera inspection station, of the

spleen, liver, heart, lungs, and mediastinal lymph nodes. In

addition, for one- and two-inspector lines under traditional

inspection, the standards are based upon the distance walked (in

feet) by the inspector between work stations; and for three or

more inspector slaughter lines, upon the use of a mirror, as

described in § 307.2(m)(6) of this chapter, at the carcass

inspection station. Although not required in a one- or two-

inspector slaughter configuration, except in certain cases as

determined by the inspection service, if a mirror is used, it

must comply with the requirements of § 307.2(m)(6).

* * * * *

7. Amend § 310.18 by adding paragraphs (c) through (d) to read

as follows:

§ 310.18 Contamination of carcasses, organs, or other parts.

* * * * *


203

(c) Procedures for controlling contamination throughout the

slaughter and dressing operation. Official swine slaughter

establishments must develop, implement, and maintain written

procedures to prevent contamination of carcasses and parts by

enteric pathogens, and visible fecal material, ingesta, and milk

contamination throughout the entire slaughter and dressing

operation. Establishments must incorporate these procedures into

their HACCP plans, or sanitation SOPs, or other prerequisite

programs. These procedures must include sampling and analysis

for microbial organisms in accordance with the sampling location

and frequency requirements in paragraphs (c)(1) and (2) of this

section to monitor their ability to maintain process control.

(1) Sampling locations. Official swine slaughter establishments,

except for very low-volume establishments, must collect and

analyze carcass samples for microbial organisms at the pre-

evisceration and post-chill points in the process.

Establishments that slaughter more than one type of livestock

must test the type of livestock slaughtered in the greatest

number. Establishments that bone their products before chilling

(i.e., hot-boned products) must collect and analyze samples at

the pre-evisceration point in the process and after the final

wash instead of at post-chill. Very low-volume establishments

must collect and analyze samples for microbial organisms at the


204

post-chill point in the process. All swine establishments must

sponge or excise tissue from the ham, belly, and jowl areas.

(i) Very low-volume establishments annually slaughter no more

than 20,000 swine, or a combination of swine and other livestock

not exceeding 6,000 cattle and 20,000 total of all livestock.

(ii) [reserved]

(2) Sampling frequency. Establishments, except for very low-

volume establishments as defined in paragraph (c)(1)(i) of this

section, must collect and analyze samples at a frequency

proportional to the establishment's volume of production at the

following rates:

(i) Establishments, except for very low-volume establishments as

defined in paragraph (c)(1)(i) of this section, must collect and

analyze samples at a frequency of once per 1,000 carcasses, but

a minimum of once during each week of operation.

(ii) Very low-volume establishments as defined in paragraph

(c)(1)(i) of this section must collect and analyze samples at

least once during each week of operation starting June 1 of

every year. If, after consecutively collecting 13 weekly

samples, very low-volume establishments can demonstrate that

they are effectively maintaining process control, they may

modify their sampling plans.


205

(iii) Establishments must maintain accurate records of all test

results and retain these records as provided in paragraph (d) of

this section.

(d) Recordkeeping requirements. Official swine slaughter

establishments must maintain daily records sufficient to

document the implementation and monitoring of the procedures

required under this section. Records required by this section

may be maintained on computers if the establishment implements

appropriate controls to ensure the integrity of the electronic

data. Records required by this section must be maintained for at

least one year and must be accessible to FSIS.

8. Amend § 310.25 as follows:

a. Remove paragraph (a)(2)(ii)(C);

b. Remove the second sentence in paragraph (a)(2)(iii)(A);

c. Remove “20,000 swine,” in paragraph (a)(2)(v)(A);

d. Remove the “swine” row in Table 1—Evaluation of E. Coli Test

Results;

e. Remove the “Hogs” and “fresh pork sausages” rows and footnote

(b) from Table 2—Salmonella Performance Standards.


§ 310.26 Establishment responsibilities under the new swine

slaughter inspection system.

(a) Facilities. The establishment must comply with the

facilities requirements in 9 CFR part 307. The establishment


206

must provide a mirror at the carcass inspection station in

accordance with 9 CFR 307.2 (m)(6).

(b) Carcass sorting and disposition. The establishment must

conduct carcass sorting activities and identify any condemnable

conditions or defects before carcasses are presented to online

inspectors. Establishment sorters must incise mandibular lymph

nodes and palpate the viscera to detect the presence of animal

diseases as part of their sorting activities. The establishment

must develop, implement, and maintain written procedures to

ensure that market hog carcasses adulterated with septicemia,

toxemia, pyemia, or cysticercosis are properly removed before

the point of post-mortem inspection of carcasses. The

establishment must incorporate these procedures into its HACCP

plan, or sanitation SOPs, or other prerequisite program. These

procedures must cover the establishment sorting activities

required under this section.

(c) Line speed limits. The line speed limits in 9 CFR 310.1 do

not apply to the establishment, provided it is able to maintain

effective process control and prevent contamination of carcasses

and parts by enteric pathogens and visible fecal material,

ingesta, and milk. Establishments operating under the NSIS must

reduce their line speed as directed by the Inspector-in-Charge

(IIC). The IIC is authorized to direct an establishment to

operate at a reduced line speed when in their judgment a


207

carcass-by-carcass inspection cannot be adequately performed

within the time available due to the manner in which the

carcasses are presented to the online inspector, the health

conditions of a particular herd, or factors that may indicate a

loss of process control.

(d) Records. (1) The establishment must maintain records to

document that the products resulting from its slaughter

operation meet the definition of Ready-to-cook pork product in 9

CFR 301.2. These records are subject to review and evaluation by

FSIS personnel.

(2) The establishment must maintain records to document the

number of carcasses disposed of per day by establishment sorters

before FSIS post-mortem inspection and the reasons that the

carcasses were disposed of. These records are subject to review

and evaluation by FSIS personnel.


§ 310.27 Attestation requirements.

Each establishment that participates in the NSIS must submit on

an annual basis an attestation to the management member of the

local FSIS circuit safety committee stating that it maintains a

program to monitor and document any work-related conditions of

establishment workers, and that the program includes the

following elements:


208

(a) Policies to encourage early reporting of symptoms of

injuries and illnesses, and assurance that it has no policies or

programs in place that would discourage the reporting of

injuries and illnesses.

(b) Notification to employees of the nature and early symptoms

of occupational illnesses and injuries, in a manner and language

that workers can understand, including by posting in a

conspicuous place or places where notices to employees are

customarily posted, a copy of the FSIS/OSHA poster encouraging

reporting and describing reportable signs and symptoms.

(c) Monitoring, on a regular and routine basis, injury and

illness logs, as well as nurse or medical office logs, workers'

compensation data, and any other injury or illness information

available.


§310.28 Severability.

Should a court of competent jurisdiction hold any provision

of 9 CFR 310.27 to be invalid, such action will not affect any

other provision of 9 CFR parts 309 or 310.

Done in Washington, DC.

Carmen M. Rottenberg,


209

Administrator.